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, Senior) |
NCT02736786 |
16-000040 |
|
March 2016 |
March 2020 |
March 2020 |
April 13, 2016 |
August 29, 2017 |
|
- 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, Senior) |
NCT02792322 |
16-001297 |
|
May 2016 |
May 2018 |
May 2019 |
June 7, 2016 |
August 22, 2017 |
|
- 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, Senior) |
NCT03144778 |
2016-0805 |
|
July 12, 2017 |
July 2020 |
July 2021 |
May 9, 2017 |
March 21, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
4 |
NCT02953197 |
Recruiting |
18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours |
|
- Radiation: FDG-PET guided radiation dose escalation
|
Interventional |
Phase 1 |
- Guy's and St Thomas' NHS Foundation Trust
- Velindre NHS Trust
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients suffering grade 3 or more late mucosal toxicity, assessed using the RTOG /EORTC and modified LENTSOMA scale, at one year post treatment
|
25 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02953197 |
RJ113/N033 |
FiGaRO |
February 2013 |
October 2018 |
October 2018 |
November 2, 2016 |
November 2, 2016 |
|
- Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom
|
5 |
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
- OPEN - 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, Senior) |
NCT03302676 |
S-20160053 |
|
September 2016 |
July 2018 |
January 2019 |
October 5, 2017 |
October 6, 2017 |
|
- Odense University Hospital
Odense, Danmark, Denmark
|
6 |
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...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT03077243 |
LCCC 1612 |
|
August 2016 |
April 2019 |
August 2046 |
March 10, 2017 |
February 21, 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
|
7 |
NCT02281955 |
Recruiting |
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study |
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
|
- Radiation: Intensity Modulated Radiotherapy (IMRT)
- Drug: Cisplatin (or alternative)
- Procedure: Assessment for surgical evaluation
|
Interventional |
Phase 2 |
- UNC Lineberger Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 2 year Progression Free Survival after de-intensified CRT in HPV-positive and/or p16 positive low-risk OPSCC
- Local control rate
- Regional control rate
- (and 5 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02281955 |
LCCC1413 |
|
August 2014 |
November 2019 |
November 2022 |
November 4, 2014 |
September 20, 2017 |
|
- University of Florida
Gainesville, Florida, United States - University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States - Pardee Memorial Hospital
Hendersonville, North Carolina, United States - (and 2 more...)
|
8 |
NCT03416153 |
Not yet recruiting |
Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer |
|
- Drug: Cetuximab
- Radiation: Radiation Therapy
|
Interventional |
Phase 2 |
- University of Michigan 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, Senior) |
NCT03416153 |
UMCC 2017.113 HUM00136258 |
|
May 2018 |
November 1, 2022 |
November 1, 2023 |
January 30, 2018 |
March 15, 2018 |
|
- University of Michigan Hospital
Ann Arbor, Michigan, United States - VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
|
9 |
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, Senior) |
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
|
10 |
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, Senior) |
NCT03210103 |
ORATOR2 |
ORATOR2 |
January 26, 2018 |
August 15, 2028 |
August 15, 2028 |
July 6, 2017 |
February 6, 2018 |
|
- London Regional Cancer Program
London, Ontario, Canada
|
11 |
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, Senior) |
NCT02945631 |
GCO 16-0609 |
|
April 2016 |
April 2023 |
April 2023 |
October 26, 2016 |
October 24, 2017 |
|
- Icahn School of Medicine at Mount Sinai
New York, New York, United States
|
12 |
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, Senior) |
NCT02908477 |
16-004083 |
|
August 2016 |
September 2024 |
September 2024 |
September 21, 2016 |
July 21, 2017 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
13 |
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, Senior) |
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
|
14 |
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, Senior) |
NCT02405000 |
D14189 |
|
April 2015 |
March 2018 |
July 2018 |
April 1, 2015 |
July 26, 2017 |
|
- Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
|
15 |
NCT02215265 |
Not yet 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, Senior) |
NCT02215265 |
2014/VCC/0014 |
PATHOS |
December 2014 |
December 2019 |
|
August 13, 2014 |
August 13, 2014 |
|
- University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom - Velindre Cancer Centre
Cardiff, United Kingdom - HPV Research Group Section of Pathology Cardiff University ,School of Medicine
Cardiff, United Kingdom - (and 5 more...)
|
16 |
NCT03435471 |
Not yet 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, Senior) |
NCT03435471 |
20180084 |
|
August 2018 |
February 2020 |
February 2021 |
February 16, 2018 |
February 16, 2018 |
|
- University of Miami
Miami, Florida, United States
|
17 |
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, Senior) |
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
|
18 |
NCT03342378 |
Not yet 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, Senior) |
NCT03342378 |
UW17078 P30CA014520 2017-1010 P50DE026787 |
|
April 2018 |
October 2020 |
October 2022 |
November 17, 2017 |
February 12, 2018 |
|
- University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
|
19 |
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, Senior) |
NCT02984410 |
EORTC-1420-HNCG-ROG |
Best Of |
November 27, 2017 |
November 2020 |
May 2026 |
December 6, 2016 |
February 28, 2018 |
|
- Cliniques Universitaires Saint-Luc
Brussels, Belgium - U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium - Kantonsspital Aarau
Aarau, Switzerland - (and 4 more...)
|
20 |
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, Senior) |
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
|
21 |
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, Senior) |
NCT02147418 |
INST 1310 |
|
February 2015 |
January 2019 |
December 2019 |
May 26, 2014 |
September 18, 2017 |
|
- University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
|
22 |
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, Senior) |
NCT01893307 |
2012-0825 NCI-2013-01879 R03CA188162 2U19CA021239 |
|
August 2013 |
August 2023 |
August 2023 |
July 9, 2013 |
September 20, 2017 |
|
- University of California at San Diego
La Jolla, California, United States - Florida Health Protocol Institute
West Palm Beach, Florida, United States - Northwestern Memorial Hospital
Chicago, Illinois, United States - (and 7 more...)
|
23 |
NCT01181648 |
Recruiting |
Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life |
- Squamous Cell Carcinoma of the Oropharynx
|
- Behavioral: questionnaire and semi-structured interviews
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- To assess quality of life in survivors
- Explore the psychosocial impact of a HPV diagnosis
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT01181648 |
10-111 |
|
August 2010 |
August 2019 |
August 2019 |
August 13, 2010 |
January 17, 2018 |
|
- Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States - Memorial Sloan Kettering West Harrison
Harrison, New York, United States - (and 3 more...)
|
24 |
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, Senior) |
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
|
25 |
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 I Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- (and 13 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, Senior) |
NCT02917629 |
NCI-2016-01407 N01-CN-2012-00033 UWI2016-07-01 N01CN00033 P30CA014520 |
|
August 14, 2017 |
June 10, 2019 |
June 10, 2019 |
September 28, 2016 |
March 5, 2018 |
|
- 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
|
26 |
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, Senior) |
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
|
27 |
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
|
|
Observational |
|
- UNC Lineberger Comprehensive Cancer Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Xerostomia
- Salivary Ductal Visibility
- Salivary Gland Volume
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03418792 |
LCCC 1735 |
|
March 8, 2018 |
March 2021 |
March 2021 |
February 1, 2018 |
March 21, 2018 |
|
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States
|
28 |
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, Senior) |
NCT03323463 |
17-409 |
|
October 16, 2017 |
October 2020 |
October 2020 |
October 27, 2017 |
March 29, 2018 |
|
- Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States - (and 3 more...)
|
29 |
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, Senior) |
NCT03215719 |
17-00330 |
|
July 10, 2017 |
July 2020 |
July 2021 |
July 12, 2017 |
July 13, 2017 |
|
- New York University School of Medicine
New York, New York, United States
|
30 |
NCT02552550 |
Recruiting |
Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx |
- Squamous Cell Carcinoma of the Oropharynx
|
- Procedure: Ability to swallow, speak and quality of life
|
Observational |
|
- Centre Hospitalier Universitaire de Saint Etienne
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- change from swallowing disorder
- Change from phonation disorder
- Change from quality of life
|
50 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02552550 |
1208112 2012-A00904-39 |
|
July 2013 |
May 2018 |
May 2019 |
September 17, 2015 |
August 11, 2017 |
|
- CHu de SAINT-ETIENNE
Saint-etienne, France
|
31 |
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, Senior) |
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
|
32 |
NCT00964977 |
Recruiting |
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. |
- Oropharyngeal Cancer
- Oral Cancer
- Lymph Node Metastasis
|
- Radiation: Radiation therapy
|
Interventional |
Phase 3 |
- Johannes Gutenberg University Mainz
- Deutsche Krebshilfe e.V., Bonn (Germany)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary study object: overall survival
- Time to occurrence of local relapse
- Time to lymphatic metastasis
- (and 2 more...)
|
560 |
All |
18 Years and older (Adult, Senior) |
NCT00964977 |
DOESAK-pN1-108399 |
|
October 2009 |
December 2013 |
December 2018 |
August 25, 2009 |
November 16, 2012 |
|
- Universiätsklinikum Tübingen
Tübingen, Baden Württemberg, Germany - Universitätsklinikum Erlangen
Erlangen, Bayern, Germany - Universitätsklinik München
München, Bayern, Germany - (and 46 more...)
|
33 |
NCT01874587 |
Recruiting |
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma |
|
- Radiation: adaptative radiotherapy
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Salivary flow measure
- Xerostomia
- Salivary flow
- (and 4 more...)
|
174 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01874587 |
2012-RdC-ORL-Th 2012-A00426-37 |
ARTIX |
July 2013 |
August 2019 |
August 2020 |
June 11, 2013 |
November 22, 2017 |
|
- Clinique Claude Bernard
Albi, France - Clinique Pasteur - Saint Esprit
Brest, France - CRLCC Baclesse
Caen, France - (and 8 more...)
|
34 |
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, Senior) |
NCT03239834 |
VIG-001 |
|
March 31, 2017 |
September 2018 |
December 2018 |
August 4, 2017 |
March 23, 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 9 more...)
|
35 |
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, Senior) |
NCT02379520 |
H-36021 HESTIA |
HESTIA |
September 2015 |
October 2018 |
October 2033 |
March 5, 2015 |
April 25, 2018 |
|
- Houston Methodist Hospital
Houston, Texas, United States
|
36 |
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, Senior) |
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
|
37 |
NCT03226613 |
Recruiting |
New Modalities for Detection of Oropharyngeal Cancer |
- Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
- Oropharynx Cancer
- Base of Tongue Carcinoma
- Tonsil Cancer
|
- Procedure: Transcervical Oropharyngeal Ultrasound
- Procedure: Oral Rinse Collection
- Procedure: Blood Draw
|
Interventional |
Not Applicable |
- Vanderbilt University Medical Center
- American Cancer Society, Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Detection of tumor via transcervical ultrasound
- HPV Serology
|
50 |
All |
21 Years and older (Adult, Senior) |
NCT03226613 |
170297 |
|
August 15, 2017 |
July 1, 2018 |
January 1, 2019 |
July 24, 2017 |
September 14, 2017 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
38 |
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, Senior) |
NCT03224000 |
2015-0851 |
|
January 17, 2018 |
January 2025 |
January 2026 |
July 21, 2017 |
January 23, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
39 |
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, Senior) |
NCT03148665 |
161215 |
Detect 44 |
April 14, 2017 |
May 30, 2019 |
May 30, 2020 |
May 11, 2017 |
May 18, 2017 |
|
- 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
|
40 |
NCT02412241 |
Recruiting |
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients |
- Oral Cavity Cancer
- Oropharyngeal Cancer
- Lymphedema
- Fibrosis
|
- Other: LEF measures
- Procedure: Technical measure
|
Interventional |
Not Applicable |
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
- Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility
- Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)
- (and 3 more...)
|
90 |
All |
21 Years and older (Adult, Senior) |
NCT02412241 |
VICC SUPP 1529 1R01DE024982-01 |
|
June 2015 |
February 2019 |
February 2019 |
April 9, 2015 |
January 25, 2018 |
|
- Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
|
41 |
NCT02981862 |
Recruiting |
CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas |
- Cervical Cancer
- Vulvar Cancer
- Anal Cancer
- Oropharynx Cancer
|
|
Interventional |
Not Applicable |
- Institut de Cancérologie de Lorraine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Assessement of CaptHPV method
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02981862 |
2016-A01085-46 |
CaptHPV |
December 19, 2016 |
December 2018 |
December 2018 |
December 5, 2016 |
April 17, 2018 |
|
- Institut de Cancérologie de Lorraine
Vandoeuvre-lès-Nancy, France
|
42 |
NCT02035735 |
Recruiting |
Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers |
- Squamous Cell Carcinoma of Oropharynx
- Squamous Cell Carcinoma of Hypopharynx
- Squamous Cell Carcinoma of Larynx
|
|
Interventional |
Not Applicable |
- University Hospital, Toulouse
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of patients for whom superficial extension of the tumors has been increased by NBI.
- Number of tumors upstaged.
- Contribution of the NBI in the diagnosis of other synchronous locations.
- (and 2 more...)
|
87 |
All |
18 Years and older (Adult, Senior) |
NCT02035735 |
13 203 02 |
|
January 2014 |
December 2017 |
December 2017 |
January 14, 2014 |
February 23, 2017 |
|
- University of Toulouse
Toulouse, France
|
43 |
NCT01984359 |
Recruiting |
HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer |
- Subjects With p16+/HPV+ Squamous Cell Carcinomas of the Oropharynx.
|
- Other: Obtaining Human tissue
|
Interventional |
Not Applicable |
- Abramson Cancer Center of the University of Pennsylvania
|
Other |
- Primary Purpose: Diagnostic
|
- Number of subjects with Adverse Events
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT01984359 |
UPCC 22313 |
|
May 2013 |
May 2017 |
|
November 14, 2013 |
September 26, 2016 |
|
- Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
44 |
NCT02960724 |
Recruiting |
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer |
- Oral Cancer
- Oropharyngeal Cancer
- Neoplasms
- (and 3 more...)
|
- Other: 68Ga-NOTA-AE105 PET/CT
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
- Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).
- Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.
- Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)
|
90 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02960724 |
AK-2016-HHC1 |
|
November 2016 |
August 2018 |
August 2018 |
November 10, 2016 |
November 10, 2016 |
|
- Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Denmark
|
45 |
NCT03422536 |
Recruiting |
Ficlatuzumab With or Without Cetuximab in Treating Patients With Cetuximab-Resistant, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
- Head and Neck Basaloid Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- (and 20 more...)
|
- Biological: Cetuximab
- Drug: Ficlatuzumab
- Other: Laboratory Biomarker Analysis
- (and 2 more...)
|
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, Senior) |
NCT03422536 |
1710965268 NCI-2017-02209 AV-299-17-117i P30CA023074 |
|
December 5, 2017 |
August 1, 2019 |
August 1, 2020 |
February 5, 2018 |
February 5, 2018 |
|
- The University of Arizona Cancer Center
Tucson, Arizona, United States
|
46 |
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, Senior) |
NCT03370276 |
MCC-19178 |
|
December 6, 2017 |
December 2021 |
December 2022 |
December 12, 2017 |
April 12, 2018 |
|
- 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
|
47 |
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, Senior) |
NCT03096808 |
17-148 |
|
March 15, 2017 |
March 15, 2019 |
March 15, 2019 |
March 30, 2017 |
March 15, 2018 |
|
- Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Commack
Commack, New York, United States - (and 3 more...)
|
48 |
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 3 more...)
|
90 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03427411 |
180056 18-C-0056 |
|
February 27, 2018 |
December 31, 2020 |
December 31, 2021 |
February 9, 2018 |
March 2, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
49 |
NCT02586207 |
Recruiting |
Pembrolizumab in Combination With CRT for LA-SCCHN |
- Head and Neck Cancer
- Squamous Cell Carcinoma
- Oral Cavity Cancer
- (and 4 more...)
|
- Drug: pembrolizumab (MK-3475)
- Drug: Cisplatin
- Radiation: Radiation
|
Interventional |
Phase 1 |
- Sanford Health
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- CTCAE 4.0 to monitor and grade adverse events. Count and percentage of AE will be provided. Fisher's exact test will be used to compare the proportions.
- The FACT-H&N questionnaire will be will be used to assess HRQOL.
|
39 |
All |
18 Years and older (Adult, Senior) |
NCT02586207 |
SH MISP203 |
|
November 2015 |
April 2018 |
September 2021 |
October 26, 2015 |
October 6, 2017 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States - Sanford-Bismarck Medical Center
Bismarck, North Dakota, United States - Sanford-Roger Maris Cancer Center
Fargo, North Dakota, United States - Sanford Health Cancer Center
Sioux Falls, South Dakota, United States
|
50 |
NCT01772706 |
Recruiting |
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer |
- Oral Squamous Cell Carcinoma
- Squamous Cell Carcinoma of Oropharynx
- Squamous Cell Carcinoma of Hypopharynx
- Oral Mucositis
|
- Procedure: low level laser therapy
- Procedure: placebo (laser low level energy nonfunctional)
|
Interventional |
Phase 3 |
- Institut Cancerologie de l'Ouest
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To evaluate the efficacy of preventive and curative low energy laser induced mucositis in patients receiving concomitant chemotherapy and radiotherapy for squamous cell carcinoma of the head and neck with stage III-IV
- To evaluate the pain by a numerical analog, in its the nature and the dosage of analgesics consumed.
- To assess the nutritional status by body weight follow-up and the capability of swallowing various foods, and biologically the serum albumin, prealbumin, and optionally a measure of body fat (impedance, skinfolds)
- (and 3 more...)
|
100 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01772706 |
CPP400 2008-003681-26 |
LaserMucite |
October 2008 |
March 2019 |
|
January 21, 2013 |
January 21, 2013 |
|
- Institut de Cancerologie de l'Ouest Paul Papin
Angers, France - Centre Guillaume le Conquérant
Le Havre, France - Hôpital La Pitié Salpêtrière
Paris, France - (and 3 more...)
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