| 1 |
NCT02736786 |
Recruiting |
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors |
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery
|
67 |
All |
18 Years and older (Adult, Older Adult) |
NCT02736786 |
16-000040 |
|
March 2016 |
March 2020 |
March 2020 |
April 13, 2016 |
October 18, 2018 |
|
- Mayo Clinic
Phoenix, Arizona, United States - Mayo Clinic
Rochester, Minnesota, United States
|
|
| 2 |
NCT02792322 |
Recruiting |
A Pilot Study Assessing Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck |
- Oropharyngeal Neoplasms
- Head and Neck Cancer
|
- Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- TORS surgery completion in the seated position
- Length of participants' surgical time
- Estimated amount of blood loss during participants' surgery
|
50 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT02792322 |
16-001297 |
|
May 2016 |
May 2020 |
May 2020 |
June 7, 2016 |
December 21, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 3 |
NCT03144778 |
Recruiting |
Checkpoint Inhibitors Assessment in Oropharynx Carcinoma (CIAO) |
- Malignant Neoplasms of Oropharynx
|
- Drug: Durvalumab
- Drug: Tremelimumab
- Behavioral: Questionnaire
- (and 3 more...)
|
Interventional
|
Early Phase 1 |
- M.D. Anderson Cancer Center
- AstraZeneca
- Stiefel, a GSK Company
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change of CD8+ Tumor Infiltrating Lymphocytes of Durvalumab Single Agent or Combined with Tremelimumab
- Adverse Events of Durvalumab Single Agent or Combined with Tremelimumab
- Objective Response Rate (ORR) of Durvalumab Single Agent or Combined with Tremelimumab
|
28 |
All |
18 Years and older (Adult, Older Adult) |
NCT03144778 |
2016-0805
NCI-2018-01199 |
|
July 12, 2017 |
July 2020 |
July 2020 |
May 9, 2017 |
November 5, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 4 |
NCT03302676 |
Recruiting |
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors |
- Head and Neck Cancer
- Radiation Therapy Complication
- Xerostomia
- Hyposalivation
|
- Dietary Supplement: Chewing gum
|
Interventional
|
Phase 3 |
- Odense University Hospital
- Danish Cancer Society
- Odense Patient Data Explorative Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Salivary flow (intervention arm)
- Salivary flow (both groups of patients)
|
210 |
All |
18 Years and older (Adult, Older Adult) |
NCT03302676 |
S-20160053 |
|
September 2016 |
August 2018 |
January 2019 |
October 5, 2017 |
August 21, 2018 |
|
- Odense University Hospital
Odense, Danmark, Denmark
|
|
| 5 |
NCT03077243 |
Recruiting |
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC |
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
|
- Radiation: Intensity Modulated Radiotherapy (IMRT) - deintensified
- Radiation: Intensity Modulated Radiotherapy (IMRT) - standard
- Drug: Cisplatin (or alternative) - deintensified
- (and 2 more...)
|
Interventional
|
Phase 2 |
- UNC Lineberger Comprehensive Cancer Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 2 year Progression Free Survival after de-intensified chemoradiation therapy (CRT) in HPV-associated OPSCC
- Changes in plasma circulating free HPV DNA during and after treatment as related to clinical outcomes in patients with HPV-associated OPSCC
- Local control rate
- (and 6 more...)
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT03077243 |
LCCC 1612 |
|
December 2016 |
May 2020 |
February 2025 |
March 10, 2017 |
May 16, 2018 |
|
- University of Florida
Gainesville, Florida, United States - University of Florida Proton Therapy Institute
Jacksonville, Florida, United States - University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States - Rex Healthcare
Raleigh, North Carolina, United States
|
|
| 6 |
NCT03838263 |
Not yet recruiting
New |
Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer |
|
- Drug: Nivolumab
- Radiation: Chemoradiation
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The rate of patients that fulfill the 3 or 5 conditions as described below (Feasibility assessment of nivolumab neoadjuvant treatment before chemoradiation)
- The incidence of Adverse Events related or not related to chemoradiation and Nivolumab
- Objective Response Rate in the experimental arm
- (and 4 more...)
|
61 |
All |
18 Years and older (Adult, Older Adult) |
NCT03838263 |
UC-0130/1804
2018-000626-60 |
IMMUNEBOOST |
March 2019 |
December 2020 |
March 2023 |
February 12, 2019 |
February 12, 2019 |
|
- Hopital Beaujon
Clichy, France - Centre Léon Bérard
Lyon, France - Centre Antoine Lacassagne
Nice, France - (and 7 more...)
|
|
| 7 |
NCT03713021 |
Not yet recruiting |
TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers |
|
- Device: TraceIT Tissue Marker
|
Interventional
|
Phase 1 |
- Washington University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Change in clinical target volumes (CTV) for the primary resection bed between the standard of care treatment plan and the treatment plan based on the TraceIT hydrogel markers
- Adverse events associated with TraceIT
|
21 |
All |
18 Years and older (Adult, Older Adult) |
NCT03713021 |
201810117 |
|
February 28, 2019 |
February 28, 2020 |
April 30, 2020 |
October 19, 2018 |
January 15, 2019 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 8 |
NCT03691441 |
Recruiting |
Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer |
|
- Procedure: Resection
- Radiation: Radiotherapy
- Drug: Chemotherapy
- Procedure: Salvage neck dissection
|
Interventional
|
Phase 4 |
- Universitätsklinikum Hamburg-Eppendorf
- Charite University, Berlin, Germany
- University Medical Center Gießen and Marburg GmbH
- University Medical Center Ulm
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to local or locoregional failure or death from any cause
- Overall survival
- Disease-free survival
- (and 5 more...)
|
280 |
All |
18 Years and older (Adult, Older Adult) |
NCT03691441 |
TopROC |
|
January 5, 2018 |
June 5, 2023 |
June 5, 2023 |
October 1, 2018 |
January 28, 2019 |
|
- Universitäts- HNO- Klinik Mannhein
Mannheim, Baden- Würtemberg, Germany - St. Vincentius- Kliniken Karlsruhe
Karlsruhe, Baden-Württemberg, Germany - Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany - (and 15 more...)
|
|
| 9 |
NCT03656133 |
Recruiting |
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers |
|
- Radiation: Radiotherapy fractionation
|
Interventional
|
Not Applicable |
- H. Lee Moffitt Cancer Center and Research Institute
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of response at week 4 of treatment
- Rate of complete response at 2-3 months
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03656133 |
MCC-19579 |
|
August 30, 2018 |
August 30, 2020 |
August 30, 2021 |
September 3, 2018 |
January 3, 2019 |
|
- H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
|
|
| 10 |
NCT03604588 |
Recruiting |
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers |
|
- Diagnostic Test: HPV OncoTect™
|
Interventional
|
Not Applicable |
- Gustave Roussy, Cancer Campus, Grand Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03604588 |
2016-A01655-46
2016/2474 |
HPV OncoTect™ |
January 17, 2018 |
January 2019 |
January 2019 |
July 27, 2018 |
July 27, 2018 |
|
- Gustave Roussy
Villejuif, Val De Marne, France
|
|
| 11 |
NCT03416153 |
Recruiting |
Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer |
|
- Drug: Cetuximab
- Radiation: Radiation Therapy
|
Interventional
|
Phase 2 |
- University of Michigan Rogel Cancer Center
- VA Ann Arbor Healthcare System
|
Other / U.S. Fed |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The percentage of patients with Local Regional Recurrence (LRR) of disease
- The proportion of patients who progress in any location
- The proportion of patients alive
- Incidence of Toxicity
|
75 |
All |
18 Years and older (Adult, Older Adult) |
NCT03416153 |
UMCC 2017.113
HUM00136258 |
|
April 27, 2018 |
November 1, 2022 |
November 1, 2023 |
January 30, 2018 |
June 19, 2018 |
|
- University of Michigan Hospital
Ann Arbor, Michigan, United States - VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
|
|
| 12 |
NCT03269344 |
Recruiting |
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer |
|
- Drug: Gabapentin
- Drug: Placebo Oral Capsule
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Change in quality of life from mucositis measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) scale.
- Change in Speech and swallow performance measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).
- Opioid Requirements, measured in morphine equivalents per day.
- (and 3 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03269344 |
HFHS-Gabapentin/RT Study |
|
June 5, 2017 |
January 2019 |
March 2019 |
August 31, 2017 |
August 31, 2017 |
|
- Henry Ford Hospital
Detroit, Michigan, United States
|
|
| 13 |
NCT03210103 |
Recruiting |
Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer |
|
- Radiation: Radiation
- Procedure: Transoral Surgery (TOS) + Neck Dissection
|
Interventional
|
Not Applicable |
- Lawson Health Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 2 year progression free survival (comparison with historical controls)
- Quality of Life 1 year post treatment
- Overall Survival
- (and 7 more...)
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT03210103 |
ORATOR2 |
ORATOR2 |
January 26, 2018 |
August 15, 2028 |
August 15, 2028 |
July 6, 2017 |
October 25, 2018 |
|
- London Regional Cancer Program
London, Ontario, Canada - Ottawa Hospital Research Institute
Ottawa, Ontario, Canada - Sunnybrook Research Institute
Toronto, Ontario, Canada
|
|
| 14 |
NCT02945631 |
Recruiting |
Quarterback 2 - Sequential Therapy With Reduced Dose Chemoradiotherapy for HPV Oropharynx Cancer |
- Locally Advanced HPV Positive Oropharynx Cancer
|
- Radiation: PTV56
- Radiation: PTV50.4
|
Interventional
|
Not Applicable |
- Icahn School of Medicine at Mount Sinai
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Progression Free Survival
- Local-regional control (LRC)
- (and 3 more...)
|
65 |
All |
18 Years and older (Adult, Older Adult) |
NCT02945631 |
GCO 16-0609 |
|
April 2016 |
April 2023 |
April 2023 |
October 26, 2016 |
October 12, 2018 |
|
- Icahn School of Medicine at Mount Sinai
New York, New York, United States
|
|
| 15 |
NCT02908477 |
Recruiting |
Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer |
|
- Radiation: Adjuvant Radiation Therapy
- Drug: Docetaxel
- Drug: Cisplatin
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events Rate
- Local/regional control
- Quality of Life
- (and 3 more...)
|
214 |
All |
18 Years and older (Adult, Older Adult) |
NCT02908477 |
16-004083 |
|
October 3, 2016 |
September 15, 2024 |
September 15, 2024 |
September 21, 2016 |
September 19, 2018 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 16 |
NCT02703493 |
Recruiting |
Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer |
|
- Radiation: Stereotactic Radiosurgery
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and dose-limiting toxicity of dose escalated stereotactic radiotherapy in patients with high-risk oropharyngeal squamous cancer using (CTCAE), version 4.03
- Disease response using Revised RECIST guideline (version 1.1)
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT02703493 |
09-309A |
|
March 2010 |
February 2019 |
October 2022 |
March 9, 2016 |
March 30, 2018 |
|
- Northwell Health- Center for Advanced Medicine
Lake Success, New York, United States
|
|
| 17 |
NCT02405000 |
Recruiting |
Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance |
|
- Other: Intraoperative CT imaging
|
Interventional
|
Not Applicable |
- Dartmouth-Hitchcock Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT02405000 |
D14189 |
|
April 2015 |
March 2019 |
July 2019 |
April 1, 2015 |
May 1, 2018 |
|
- Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
|
|
| 18 |
NCT02215265 |
Recruiting |
Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS) |
- Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer
|
- Drug: Cisplatin
- Radiation: Postoperative radiotherapy
|
Interventional
|
Phase 2
Phase 3 |
- Lisette Nixon
- Velindre NHS Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase II: Patient-reported swallowing outcome
- Swallowing panel including qualitative and quantitative swallowing assessments
- QOL (using validated EORTC QLQ C30 and HN35 questionnaires)
- (and 3 more...)
|
242 |
All |
18 Years and older (Adult, Older Adult) |
NCT02215265 |
2014/VCC/0014 |
PATHOS |
October 2015 |
February 2020 |
February 2024 |
August 13, 2014 |
October 26, 2018 |
|
- Poole Hospital NHS Foundation Trust
Poole, Dorset, United Kingdom - Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom - Queen Elizabeth Hospital
Birmingham, United Kingdom - (and 23 more...)
|
|
| 19 |
NCT03555721 |
Recruiting |
CytID Analysis of Oral Lesions |
- Oral Cavity Cancer
- Oropharyngeal Cancer
|
- Other: Oral examination with incandescent light
- Other: Oral examination with OralID
- Diagnostic Test: Biopsy
- (and 2 more...)
|
Observational
|
|
- The University of Texas Health Science Center, Houston
- M.D. Anderson Cancer Center
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
- Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV
- Number of participants for whom biopsy results, but not CytID results, indicate presence of malignant or premalignant oral lesions
- (and 3 more...)
|
50 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03555721 |
HSC-GEN-17-1067 |
|
May 30, 2018 |
November 1, 2019 |
November 1, 2019 |
June 13, 2018 |
October 10, 2018 |
|
- The University of Texas Health Science Center at Houston
Houston, Texas, United States
|
|
| 20 |
NCT03822897 |
Not yet recruiting
New |
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma |
|
- Radiation: Radiation
- Drug: Cisplatin
|
Interventional
|
Phase 2 |
- Canadian Cancer Trials Group
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event-free Survival
- Overall Survival
- Local control
- (and 3 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT03822897 |
HN10 |
EVADER |
January 31, 2019 |
December 31, 2023 |
December 31, 2024 |
January 30, 2019 |
January 30, 2019 |
|
|
|
| 21 |
NCT03811015 |
Not yet recruiting
New |
Nivolumab Versus Observation in Treating Patients With Locally Advanced, Intermediate Risk HPV-Positive Oropharyngeal Cancer |
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Human Papillomavirus-16 Positive
- (and 3 more...)
|
- Drug: Cisplatin
- Radiation: Intensity-Modulated Radiation Therapy
- Biological: Nivolumab
- Other: Patient Observation
|
Interventional
|
Phase 2
Phase 3 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS) (Phase II)
- Overall survival (OS) (Phase III)
- Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT
- (and 8 more...)
|
744 |
All |
18 Years and older (Adult, Older Adult) |
NCT03811015 |
NCI-2019-00179
EA3161
U10CA180820 |
|
July 10, 2019 |
January 1, 2027 |
January 1, 2027 |
January 21, 2019 |
February 6, 2019 |
|
|
|
| 22 |
NCT03735745 |
Recruiting |
Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH) |
|
- Other: Blood collection
- Other: Saliva collection
- Other: Tissue collection
- Other: Surveys
|
Interventional
|
Not Applicable |
- Medical University of South Carolina
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Count of patients who have research blood, saliva and tissue samples collected.
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03735745 |
102812 |
|
January 25, 2019 |
December 30, 2020 |
December 30, 2020 |
November 8, 2018 |
January 31, 2019 |
|
- Medical University of South Carolina
Charleston, South Carolina, United States
|
|
| 23 |
NCT03669718 |
Recruiting |
A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC |
- Squamous Cell Carcinoma of the Oropharynx
- HPV16 Positive
|
- Biological: ISA101b
- Drug: Cemiplimab
- Other: Placebo
|
Interventional
|
Phase 2 |
- ISA Pharmaceuticals
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Overall Response Rate
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 "Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0".
- Duration of response (DOR) by independent review in subjects randomized to receive ISA101b plus cemiplimab compared to placebo plus cemiplimab.
|
164 |
All |
18 Years and older (Adult, Older Adult) |
NCT03669718 |
ISA101b-HN-01-17 |
|
November 30, 2018 |
February 2020 |
February 2022 |
September 13, 2018 |
February 18, 2019 |
|
- City of Hope
Duarte, California, United States - UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States - M. D. Anderson Cancer Center
Houston, Texas, United States - (and 8 more...)
|
|
| 24 |
NCT03644563 |
Recruiting |
Men and Women Offering Understanding of Throat HPV |
- Oropharyngeal Cancer
- Human Papilloma Virus
|
|
Observational
|
|
- Johns Hopkins Bloomberg School of Public Health
- Icahn School of Medicine at Mount Sinai
- Oregon Health and Science University
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Oncogenic oral HPV infection present or absent in oral rinse sample
- HPV16 E6 antibodies present or absent in serum sample
|
3000 |
All |
18 Years to 79 Years (Adult, Older Adult) |
NCT03644563 |
IRB00119537
R35DE026631 |
MOUTH |
April 3, 2017 |
April 2024 |
June 2024 |
August 23, 2018 |
December 7, 2018 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
|
| 25 |
NCT03435471 |
Recruiting |
Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer |
- Head and Neck Cancer
- Oropharynx Cancer
|
- Other: Prophylactic Swallowing Home Exercise Program
- Other: Penetration/Aspiration Scale
- Other: Functional Oral Intake Scale
- (and 4 more...)
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Immediate Change (4 weeks, +/- 2 weeks) in Swallowing Function after Clinician-Directed Prophylactic Swallowing therapy Versus Patient-Directed Home Swallowing Therapy
- Short-Term Change (26 weeks, +/- 4 weeks) in Swallowing Function after Clinician-Directed Prophylactic Swallowing Therapy
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03435471 |
20180084 |
|
September 17, 2018 |
August 2020 |
August 2021 |
February 16, 2018 |
September 19, 2018 |
|
- University of Miami
Miami, Florida, United States
|
|
| 26 |
NCT03423264 |
Recruiting |
PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing |
- Oropharyngeal Cancer
- HPV-Related Squamous Cell Carcinoma
|
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Rate of opioid use at end of radiation treatment
- Total opioid dosage during radiation treatment
- Differences in head and neck symptoms
- (and 6 more...)
|
46 |
All |
18 Years and older (Adult, Older Adult) |
NCT03423264 |
IRB17-1550 |
|
January 22, 2018 |
June 2020 |
June 2020 |
February 6, 2018 |
February 6, 2018 |
|
- University of Chicago Medical Center
Chicago, Illinois, United States
|
|
| 27 |
NCT03342378 |
Recruiting |
PET-MRI Assessment of Early Tumor Response to Predict Outcomes of HPV-Positive Oropharynx Cancer Patients |
- Squamous Cell Carcinoma
- Oropharynx Cancer
|
- Radiation: Intensity modulated radiotherapy (IMRT)
- Drug: Chemotherapy
- Diagnostic Test: PET-MRI
|
Observational
|
|
- University of Wisconsin, Madison
- National Cancer Institute (NCI)
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To determine if the primary tumor response in patients with IR HPV-positive
- To define the difference of the primary tumor response in patients with LR HPV-positive OPSCC and HPV-negative OPSCC following 2 weeks of CRT.
|
58 |
All |
18 Years and older (Adult, Older Adult) |
NCT03342378 |
UW17078
P30CA014520
2017-1010
P50DE026787 |
|
May 3, 2018 |
October 2020 |
October 2022 |
November 17, 2017 |
June 27, 2018 |
|
- University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
|
|
| 28 |
NCT02984410 |
Recruiting |
Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma |
|
- Radiation: Intensity-Modulated Radiation Therapy (IMRT)
- Procedure: Trans Oral Surgery (TOS)
|
Interventional
|
Not Applicable |
- European Organisation for Research and Treatment of Cancer - EORTC
- Swiss Group for Clinical Cancer Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in the MD Anderson Dysphagia Inventory (MDADI) score
|
170 |
All |
18 Years and older (Adult, Older Adult) |
NCT02984410 |
EORTC-1420-HNCG-ROG |
Best Of |
November 27, 2017 |
November 2020 |
May 2026 |
December 6, 2016 |
December 4, 2018 |
|
- Cliniques Universitaires Saint-Luc
Brussels, Belgium - U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium - Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, France - (and 8 more...)
|
|
| 29 |
NCT02365844 |
Recruiting |
Multispectral Imaging to Characterize Patterns of Vascular Supply Within Lymphoepithelial Mucosa in Oropharyngeal Cancer |
- Oropharyngeal Carcinoma
- Oropharynx Cancer
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- assessment of differential vascularity between normal and clinically apparent tumor with in the specified sites of oropharynx, using standard white-light endoscopy and narrow-band imaging
|
77 |
All |
18 Years and older (Adult, Older Adult) |
NCT02365844 |
ENT0044 |
|
February 2015 |
October 31, 2018 |
October 31, 2018 |
February 19, 2015 |
July 30, 2018 |
|
- Stanford University, School of Medicine
Stanford, California, United States
|
|
| 30 |
NCT02159703 |
Recruiting |
A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer |
|
- Procedure: TORS
- Radiation: Adjuvant Radiation Therapy
|
Interventional
|
Phase 2 |
- Abramson Cancer Center of the University of Pennsylvania
|
Other |
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
|
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT02159703 |
UPCC 40313 |
|
February 2014 |
February 2018 |
|
June 10, 2014 |
August 1, 2017 |
|
- Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 31 |
NCT02147418 |
Recruiting |
Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma |
|
|
Observational
|
|
- New Mexico Cancer Care Alliance
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Cultured Cell Exosome Protein Signature Outcome Measure
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02147418 |
INST 1310 |
|
February 2015 |
January 2020 |
December 2020 |
May 26, 2014 |
December 21, 2018 |
|
- University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
|
|
| 32 |
NCT01893307 |
Recruiting |
Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck |
|
- Radiation: Intensity-Modulated X-Ray Therapy (IMRT)
- Radiation: Intensity-Modulated Proton Beam Therapy (IMPT)
- Procedure: Modified barium swallow (MBS)
- Behavioral: Questionnaires
|
Interventional
|
Phase 2
Phase 3 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- National Institute of Dental and Craniofacial Research (NIDCR)
- Massachusetts General Hospital
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rates and Severity of Late Grade 3-5 Toxicity Between Intensity-Modulated X-Ray Therapy (IMRT) and Intensity-Modulated Proton Beam Therapy (IMPT)
- Progression-Free Survival (PFS) Between Concurrent Chemo-Radiation Strategies with IMRT and IMPT Following the Treatment of Oropharyngeal Tumors
|
360 |
All |
18 Years and older (Adult, Older Adult) |
NCT01893307 |
2012-0825
NCI-2013-01879
R03CA188162
2U19CA021239 |
|
August 2013 |
August 2023 |
August 2023 |
July 9, 2013 |
July 31, 2018 |
|
- Mayo Clinic - Arizona
Scottsdale, Arizona, United States - University of California at San Diego
La Jolla, California, United States - Florida Health Protocol Institute
West Palm Beach, Florida, United States - (and 8 more...)
|
|
| 33 |
NCT02757222 |
Recruiting |
Dose Escalation Versus Standard in Laryngopharyngeal Cancers |
- Malignant Neoplasm of Oropharynx Stage III
- Malignant Neoplasm of Larynx Stage III
- Malignant Neoplasm of Hypopharynx Stage III
- (and 5 more...)
|
- Radiation: Escalated Dose
- Radiation: Standard Dose
|
Interventional
|
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with Grade 3 through grade 5 adverse events that are related to dose escalation, graded according to NCI CTCAE version 4.0
- Efficacy (improvement in complete response rates at 2 years) of dose escalation in intermediate and high risk Oropharyngeal cancer (OPC) patients and in node positive, locally advanced Laryngeal and Hypopharyngeal cancer patients.
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02757222 |
EC/TMC/38/14 |
INTELHOPE |
January 2016 |
June 2018 |
December 2020 |
May 2, 2016 |
April 17, 2018 |
|
- Tata Medical Centre
Kolkata, West Bengal, India
|
|
| 34 |
NCT02917629 |
Recruiting |
ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment |
- Oral Cavity Neoplasm
- Oropharyngeal Neoplasm
- Stage 0 Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- (and 11 more...)
|
- Other: Laboratory Biomarker Analysis
- Drug: Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet
- Other: Pharmacological Study
- Other: Placebo
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Absolute change in proliferation index (Ki-67) expression, assessed in tumor tissue by immunohistochemistry
- Change in Ki-67 expression in visually normal appearing tissue, assessed by immunohistochemistry
- Change in cleaved caspase 3 expression in visually normal appearing tissue and tumor tissue samples, assessed by immunohistochemistry
- (and 5 more...)
|
39 |
All |
18 Years and older (Adult, Older Adult) |
NCT02917629 |
NCI-2016-01407
N01-CN-2012-00033
UWI2016-07-01
N01CN00033
P30CA014520 |
|
August 14, 2017 |
March 31, 2019 |
March 31, 2019 |
September 28, 2016 |
February 6, 2019 |
|
- Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States - University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States - University of Rochester
Rochester, New York, United States - University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
|
|
| 35 |
NCT03258008 |
Recruiting |
Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer |
- Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites
- Malignant Neoplasms of Lip Oral Cavity and Pharynx
- Oropharyngeal Cancer
|
- Drug: Utomilumab
- Biological: ISA101b
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- ISA Pharmaceuticals B.V.
- Pfizer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR) of Utomilumab Combined with ISA 101b in Patients with Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- Adverse Events of Utomilumab Combined with ISA 101b in Patients with Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- Response Rate by irRC of Utomilumab Combined with ISA 101b in Patients with Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- Immune-Related Progression Free Survival (PFS) of Utomilumab Combined with ISA 101b in Patients with Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
27 |
All |
18 Years and older (Adult, Older Adult) |
NCT03258008 |
2017-0145 |
|
April 4, 2018 |
June 2019 |
June 2020 |
August 22, 2017 |
April 6, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 36 |
NCT03618134 |
Recruiting |
Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner |
- Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- (and 6 more...)
|
- Biological: Durvalumab
- Procedure: Modified Radical Neck Dissection
- Other: Quality-of-Life Assessment
- (and 4 more...)
|
Interventional
|
Phase 1
Phase 2 |
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events (Phase I safety lead-in) assessed Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 criteria
- Progression-free survival (PFS) (Phase II)
- Incidence of grade >= adverse events (Phase II)
- (and 10 more...)
|
82 |
All |
18 Years and older (Adult, Older Adult) |
NCT03618134 |
17-001204
NCI-2018-01214
P30CA016042 |
|
October 4, 2018 |
October 1, 2022 |
October 1, 2023 |
August 7, 2018 |
October 24, 2018 |
|
- UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
|
|
| 37 |
NCT03611205 |
Not yet recruiting |
Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy |
- Oropharyngeal Squamous Cell Carcinoma
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
|
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
|
Interventional
|
Not Applicable |
- Ohio State University Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment
- Tumor burden
- Response rate for each patient local control
- (and 4 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03611205 |
OSU-18030
NCI-2018-01322
P30CA016058 |
|
September 1, 2018 |
December 31, 2020 |
December 31, 2020 |
August 2, 2018 |
August 2, 2018 |
|
- Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
|
|
| 38 |
NCT03418792 |
Recruiting |
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx |
- Head and Neck Cancer
- Oropharynx Cancer
- Xerostomia Due to Radiotherapy
|
- Other: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
|
Interventional
|
Not Applicable |
- UNC Lineberger Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Xerostomia
- Salivary Ductal Visibility
- Salivary Gland Volume
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03418792 |
LCCC 1735 |
|
March 8, 2018 |
March 2021 |
March 2021 |
February 1, 2018 |
September 25, 2018 |
|
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States
|
|
| 39 |
NCT03323463 |
Recruiting |
Major Radiation Reduction for HPV+ Oropharyngeal Carcinoma |
- HPV-Associated Oropharyngeal Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Neck
|
- Diagnostic Test: F-FMISO PET/CT Scan
- Radiation: 30 Gy over 3 weeks
- Drug: Cisplatin
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effectiveness of study treatment for participants receiving de-escalated radiation therapy radiation therapy, comparable to participants treated with the current standard of care chemoradiation by standard CT (or MRI) or tumor site and PET scan
|
76 |
All |
18 Years and older (Adult, Older Adult) |
NCT03323463 |
17-409 |
|
October 16, 2017 |
October 2020 |
October 2020 |
October 27, 2017 |
February 6, 2019 |
|
- Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States - (and 4 more...)
|
|
| 40 |
NCT03215719 |
Recruiting |
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma |
- Oropharyngeal Carcinoma
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
|
- Radiation: Standard Radiation Treatment
- Radiation: Dose-Deescalated Treatment
- Drug: Cisplatinum
|
Interventional
|
Phase 2 |
- New York University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival at 2 years
|
54 |
All |
18 Years and older (Adult, Older Adult) |
NCT03215719 |
17-00330 |
|
July 10, 2017 |
July 2020 |
July 2021 |
July 12, 2017 |
July 6, 2018 |
|
- New York University School of Medicine
New York, New York, United States
|
|
| 41 |
NCT02277548 |
Recruiting |
A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck. |
- Oropharyngeal Cancer
- Squamous Cell Carcinoma to the Head and Neck
|
|
Interventional
|
Not Applicable |
- Abramson Cancer Center of the University of Pennsylvania
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
|
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT02277548 |
UPCC 43313 |
|
May 2014 |
April 2018 |
|
October 29, 2014 |
August 1, 2017 |
|
- Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 42 |
NCT03239834 |
Recruiting |
Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making |
- Palatal Neoplasms
- Lip Neoplasm
- Gingival Neoplasms
- (and 4 more...)
|
|
Observational
|
|
- Vigilant Biosciences, Inc.
- Pearl Pathways
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Association of RAPID results with oral cavity / oropharyngeal biopsy.
- Association of RAPID results with the clinical decision process for avoiding an immediate biopsy.
|
1000 |
All |
23 Years and older (Adult, Older Adult) |
NCT03239834 |
VIG-001 |
|
March 31, 2017 |
September 30, 2019 |
December 31, 2019 |
August 4, 2017 |
November 8, 2018 |
|
- Joel Epstein
Beverly Hills, California, United States - Biosolutions Clinical Research Center
La Mesa, California, United States - Loma Linda School of Dentistry
Loma Linda, California, United States - (and 17 more...)
|
|
| 43 |
NCT02379520 |
Recruiting |
HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA |
- Human Papillomavirus-Related Carcinoma
- Human Papillomavirus Positive Oropharyngeal Carcinoma
- Human Papillomavirus Positive Cervical Carcinoma
- (and 3 more...)
|
- Genetic: HPV Specific T Cells
- Drug: Cytoxan
- Drug: Fludarabine
- Biological: Nivolumab
|
Interventional
|
Phase 1 |
- Baylor College of Medicine
- Center for Cell and Gene Therapy, Baylor College of Medicine
- The Methodist Hospital System
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with dose limiting toxicity (DLT)
- Overall response rate
|
32 |
All |
18 Years and older (Adult, Older Adult) |
NCT02379520 |
H-36021 HESTIA |
HESTIA |
September 2015 |
October 2019 |
October 2033 |
March 5, 2015 |
December 13, 2018 |
|
- Houston Methodist Hospital
Houston, Texas, United States
|
|
| 44 |
NCT03715946 |
Recruiting |
Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer |
- Carcinoma, Squamous Cell of Head and Neck
- Oropharynx Squamous Cell Carcinoma
|
- Drug: Nivolumab Injection
- Radiation: Radiotherapy (RT)
|
Interventional
|
Phase 2 |
- Robert Ferris
- Bristol-Myers Squibb
- University of Pittsburgh
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- PEG tube dependence
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- (and 8 more...)
|
135 |
All |
18 Years and older (Adult, Older Adult) |
NCT03715946 |
HCC 18-034 |
|
November 1, 2018 |
August 31, 2020 |
August 31, 2021 |
October 23, 2018 |
November 14, 2018 |
|
- UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
|
|
| 45 |
NCT03418909 |
Recruiting |
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma |
- Oropharynx Cancer
- Pain
- Swallowing Disorder
- (and 3 more...)
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Altered salivatory function
- Change to quality of life scores (MDADI)
- Change to quality of life scores (EORTC QLQ-C30)
- (and 4 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03418909 |
H-1-2014-033
H-17015164 |
|
April 1, 2017 |
March 31, 2020 |
March 31, 2021 |
February 1, 2018 |
February 2, 2018 |
|
- Rigshospitalet
Copenhagen, Denmark
|
|
| 46 |
NCT03224000 |
Recruiting |
Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer |
- Malignant Neoplasms of Lip Oral Cavity and Pharynx
- Oropharyngeal Cancer
|
- Procedure: Modified Barium Swallow (MBS)
- Behavioral: Swallowing Questionnaire
- Behavioral: Symptom Questionnaire
- (and 4 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Locoregional Control
- Composite Dysphagia Outcome Determined by PEG Tube Dependence at Last Follow-Up
- Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study
- (and 13 more...)
|
75 |
All |
18 Years and older (Adult, Older Adult) |
NCT03224000 |
2015-0851
NCI-2018-01109 |
|
January 17, 2018 |
January 2025 |
January 2026 |
July 21, 2017 |
July 13, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 47 |
NCT03148665 |
Recruiting |
Saliva-based Detection of CD44 |
- Oral Cavity Squamous Cell Carcinoma
- Oropharynx Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Oropharynx
- Squamous Cell Carcinoma of the Head and Neck
|
|
Interventional
|
Not Applicable |
- Joseph Califano
- Vigilant Biosciences, Inc.
- Greater Baltimore Medical Center
- (and 4 more...)
|
Other / Industry / U.S. Fed |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
- To prospectively validate the performance of pretreatment Vigilant Oral Rinse Point of Care strip and Sol CD44 as a predictor of outcome for oral/oropharyngeal cancer in a point of care multi-institutional clinical setting
- To determine the association of post treatment salivary solCD44 and the Vigilant Oral Rinse Point of Care strip with disease outcome in oral/oropharyngeal cancer
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03148665 |
161215 |
Detect 44 |
April 14, 2017 |
May 30, 2019 |
May 30, 2020 |
May 11, 2017 |
August 24, 2018 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States - Greater Baltimore Medical Center
Baltimore, Maryland, United States - Johns Hopkins School of Medicine
Baltimore, Maryland, United States - New York University College of Dentistry
New York, New York, United States
|
|
| 48 |
NCT03729518 |
Recruiting |
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck |
- Oropharyngeal Cancer
- Squamous Cell Carcinoma
- Human Papilloma Virus
|
- Radiation: Radiation Therapy (IMRT or IMPT)
|
Interventional
|
Phase 2 |
- Abramson Cancer Center of the University of Pennsylvania
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 2-year locoregional control
- Treatment-related toxicity
- 2-year progression-free survival
- (and 5 more...)
|
118 |
All |
18 Years and older (Adult, Older Adult) |
NCT03729518 |
831188-15318 |
|
October 11, 2018 |
October 11, 2022 |
October 11, 2024 |
November 2, 2018 |
November 2, 2018 |
|
- University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 49 |
NCT01084733 |
Recruiting |
Nicotine Levels With Response Rates to Radiation Alone or With Chemo In Head & Neck Cancer |
- Larynx Cancer
- Lip Cancer
- Oral Cavity Cancer
- (and 2 more...)
|
|
Observational
|
|
- Mahesh Kudrimoti
- University of Kentucky
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Correlation of serum cotinine with volumetric response
- Correlation of serum cotinine with toxicities during treatment.
- Correlation of serum cotinine with time to progression.
- (and 3 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT01084733 |
MCC-06-0781-P3K
NICOTINE-HN |
|
August 2007 |
November 15, 2019 |
November 2020 |
March 10, 2010 |
August 15, 2018 |
|
- Markey Cancer Center
Lexington, Kentucky, United States
|
|
| 50 |
NCT03370276 |
Recruiting |
Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma |
- Squamous Cell Carcinoma of the Oropharynx
- Squamous Cell Carcinoma of the Larynx
- Squamous Cell Carcinoma of the Oral Cavity
- (and 5 more...)
|
- Drug: Nivolumab
- Drug: Cetuximab
|
Interventional
|
Phase 1
Phase 2 |
- H. Lee Moffitt Cancer Center and Research Institute
- James and Esther King Biomedical Research Program
- Eli Lilly and Company
- Bristol-Myers Squibb
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Recommended Phase 2 Dose (RP2D)
- Phase II: Overall Survival (OS) Rate
- Overall Response Rate (ORR)
- (and 2 more...)
|
52 |
All |
18 Years and older (Adult, Older Adult) |
NCT03370276 |
MCC-19178 |
|
December 6, 2017 |
December 2021 |
December 2022 |
December 12, 2017 |
February 15, 2019 |
|
- H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States - Emory University School of Medicine
Atlanta, Georgia, United States - The Ohio State University
Columbus, Ohio, United States
|
|
| 51 |
NCT03096808 |
Recruiting |
Adaptive Radiotherapy for Head and Neck Cancer |
- Head and Neck Cancer
- Paranasal Sinus Cancer
- Oropharynx Cancer
- (and 4 more...)
|
- Radiation: Adaptive Radiotherapy
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with locoregional recurrence-free interval
|
65 |
All |
18 Years and older (Adult, Older Adult) |
NCT03096808 |
17-148 |
|
March 15, 2017 |
March 15, 2019 |
March 15, 2019 |
March 30, 2017 |
September 11, 2018 |
|
- Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States - (and 4 more...)
|
|
| 52 |
NCT03427411 |
Recruiting |
M7824 in Subjects With HPV Associated Malignancies |
- Human Papilloma Virus
- Cervical Cancer
- Oropharyngeal Cancer
- (and 2 more...)
|
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response rate (ORR)
- duration of response
- overall survival (OS)
- (and 4 more...)
|
120 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT03427411 |
180056
18-C-0056 |
|
February 27, 2018 |
December 31, 2020 |
December 31, 2021 |
February 9, 2018 |
January 9, 2019 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 53 |
NCT03422536 |
Recruiting |
Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma |
- Head and Neck Basaloid Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- (and 21 more...)
|
- Biological: Cetuximab
- Drug: Ficlatuzumab
|
Interventional
|
Phase 2 |
- University of Arizona
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival
- Biomarker analysis
- Change in quality of life
- (and 3 more...)
|
74 |
All |
18 Years and older (Adult, Older Adult) |
NCT03422536 |
1710965268
NCI-2017-02209
AV-299-17-117i
P30CA023074 |
|
December 5, 2017 |
August 1, 2019 |
August 1, 2020 |
February 5, 2018 |
July 11, 2018 |
|
- The University of Arizona Cancer Center
Tucson, Arizona, United States
|
|
| 54 |
NCT03082534 |
Recruiting |
Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma |
- HNSCC
- Lip SCC
- Oral Cavity Cancer
- (and 9 more...)
|
- Drug: Pembrolizumab, Cetuximab
|
Interventional
|
Phase 2 |
- Assuntina G. Sacco
- Merck Sharp & Dohme Corp.
- University of California, San Diego
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate
- Progression Free Survival Probability
- Overall Survival
- (and 3 more...)
|
83 |
All |
18 Years and older (Adult, Older Adult) |
NCT03082534 |
160621
MISP 52211 |
|
March 28, 2017 |
May 27, 2019 |
May 2020 |
March 17, 2017 |
May 23, 2018 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States
|
|
| 55 |
NCT03174275 |
Recruiting |
Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma |
- Carcinoma, Squamous Cell
- Oral Cancer
- Oropharynx Cancer
- (and 3 more...)
|
- Drug: Durvalumab
- Drug: Carboplatin
- Drug: Nab-paclitaxel
- (and 3 more...)
|
Interventional
|
Phase 2 |
- UNC Lineberger Comprehensive Cancer Center
- AstraZeneca
- Celgene
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic complete response rate (pCRR) after induction chemotherapy with carboplatin, nab-paclitaxel, and durvalumab in previously untreated stage III and IV SCCHN amenable to surgical resection
- Clinical complete response rate and (cCRR) and clinical response rate (cRR) following induction chemotherapy
- Percent of patients who have a change in estimated risk level
- (and 3 more...)
|
39 |
All |
18 Years and older (Adult, Older Adult) |
NCT03174275 |
LCCC 1621 |
|
December 19, 2017 |
September 1, 2021 |
September 1, 2026 |
June 2, 2017 |
January 29, 2019 |
|
- Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
|
|
| 56 |
NCT01847326 |
Recruiting |
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer |
- Recurrent Salivary Gland Cancer
- Recurrent Squamous Cell Carcinoma of the Hypopharynx
- Recurrent Squamous Cell Carcinoma of the Larynx
- (and 8 more...)
|
- Drug: carboplatin
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
- Drug: fluorouracil
- (and 5 more...)
|
Interventional
|
Phase 1 |
- University of Chicago
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0
- Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with radiation therapy, determined according to incidence of DLT graded using the NCI CTCAE 4.0
- PFS
- (and 2 more...)
|
61 |
All |
18 Years and older (Adult, Older Adult) |
NCT01847326 |
12-1554
NCI-2012-02179 |
|
March 2013 |
April 2018 |
December 2018 |
May 6, 2013 |
May 23, 2017 |
|
- University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
|
|
| 57 |
NCT02245100 |
Recruiting |
Circulating Tumor DNA in Predicting Outcomes in Patients With Stage IV Head and Neck Cancer or Stage III-IV Non-small Cell Lung Cancer |
- Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
- Salivary Gland Squamous Cell Carcinoma
- Stage IIIA Non-small Cell Lung Cancer
- (and 27 more...)
|
- Other: Cytology specimen
- Other: Laboratory biomarker analysis
|
Observational
|
|
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Thomas Jefferson University
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Predictive value of circulating tumor DNA for disease-free survival (DFS)/progression-free survival (PFS)
- Correlation between plasma tumor DNA levels and salivary tumor DNA levels
- Association between absence and presence of circulating tumor DNA mutation with the tumor burden
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02245100 |
14D.172
2014-010 |
|
July 22, 2014 |
July 2019 |
January 2020 |
September 19, 2014 |
January 25, 2019 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
|
| 58 |
NCT02012699 |
Recruiting |
Integrated Cancer Repository for Cancer Research |
- Pancreatic Cancer
- Thyroid Cancer
- Lung Cancer
- (and 44 more...)
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Development and implementation of a web-based Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC)
- Procurement and banking of excess biological material for future analysis
|
9999 |
All |
19 Years to 110 Years (Adult, Older Adult) |
NCT02012699 |
253-13 |
iCaRe2 |
November 2013 |
December 2099 |
December 2099 |
December 16, 2013 |
November 5, 2018 |
|
- University of Alabama Birmingham
Birmingham, Alabama, United States - Penrose Cancer Center
Colorado Springs, Colorado, United States - Halifax Health Medical Center d/b/a Halifax Health
Daytona Beach, Florida, United States - (and 67 more...)
|
|
| 59 |
NCT01365169 |
Recruiting |
Post-op Wellness Program for Pancreatic Cancer Patients That Uses Patient Feedback and Real-time Provider Monitoring |
- Cancer Survivor
- Current Smoker
- Former Smoker
- (and 48 more...)
|
- Behavioral: Exercise Intervention
- Other: Health Telemonitoring
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
|
Interventional
|
Not Applicable |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
|
290 |
All |
18 Years and older (Adult, Older Adult) |
NCT01365169 |
2010-0955
NCI-2014-02468
P30CA016672
R01CA177996
RC2CA148263 |
|
May 25, 2011 |
June 30, 2019 |
June 30, 2019 |
June 3, 2011 |
November 12, 2018 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 60 |
NCT03829033 |
Recruiting
New |
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer. |
|
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Acute side effects.
- Late side effects.
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT03829033 |
Version 2 2018-10-10 |
ARTSCAN V |
January 22, 2019 |
January 2028 |
January 2028 |
February 4, 2019 |
February 4, 2019 |
|
- Gävle Hospital
Gävle, Sweden - Sahlgrenska University Hospital
Göteborg, Sweden - Jönköping Hospital
Jönköping, Sweden - (and 9 more...)
|
|
| 61 |
NCT03799445 |
Not yet recruiting |
Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma |
- CDKN2A-p16 Positive
- Human Papillomavirus DNA
- Human Papillomavirus mRNA
- (and 7 more...)
|
- Radiation: Intensity-Modulated Radiation Therapy
- Biological: Ipilimumab
- Biological: Nivolumab
- (and 2 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose limiting toxicity (DLT) (safety lead-in)
- Complete response rate (Phase II)
- Progression-free survival (PFS) (Phase II)
- (and 10 more...)
|
180 |
All |
18 Years and older (Adult, Older Adult) |
NCT03799445 |
2018-0381
NCI-2018-03260
P30CA016672 |
|
May 7, 2019 |
April 28, 2021 |
April 28, 2021 |
January 10, 2019 |
January 15, 2019 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 62 |
NCT03602079 |
Recruiting |
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene |
- HER2-positive Breast Cancer
- HER2 Gene Mutation
- HER-2 Gene Amplification
- (and 41 more...)
|
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Maximum Tolerated Dose
- Phase II: Percentage of patients with an Objective Response Rate (ORR) [Complete Response (CR) + Partial Response (PR)]
- Phase I: Number of patients with Dose Limiting Toxicities
- (and 13 more...)
|
82 |
All |
18 Years and older (Adult, Older Adult) |
NCT03602079 |
KlusPharma |
|
July 16, 2018 |
October 2020 |
May 2021 |
July 26, 2018 |
January 15, 2019 |
|
- Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States - Beth Israel Deaconess Medical Center Cancer Center
Boston, Massachusetts, United States - Karmanos Cancer Institute
Detroit, Michigan, United States - (and 7 more...)
|
|
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