| 1 |
NCT03325465 |
Not yet recruiting |
Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Pembrolizumab
- Drug: Epacadostat
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of major treatment effect (rate of treatment response)
- Rate of complete response
- Progression free survival rate
- (and 3 more...)
|
44 |
All |
18 Years and older (Adult, Senior) |
NCT03325465 |
IRB17-0993 |
|
May 2018 |
June 2020 |
June 2020 |
October 30, 2017 |
April 18, 2018 |
|
- University of Chicago
Chicago, Illinois, United States
|
| 2 |
NCT03341936 |
Recruiting |
Adjuvant Nivolumab and Lirilumab in Patients With Relapsed, Resectable Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Nivolumab
- Drug: Lirilumab
|
Interventional |
Phase 2 |
- Dana-Farber Cancer Institute
- Bristol-Myers Squibb
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free survival
- Best overall Response Rate
- Overall Survival Rate
|
58 |
All |
18 Years and older (Adult, Senior) |
NCT03341936 |
17-411 |
|
March 15, 2018 |
June 30, 2021 |
June 30, 2025 |
November 14, 2017 |
March 29, 2018 |
|
- Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
| 3 |
NCT03129061 |
Recruiting |
Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
|
Interventional |
Phase 1 |
- CellSight Technologies, Inc.
- Stanford University
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Non-invasive assessment of T cell activation at tumor site from anti-PD1 therapy as measured by signal changes with VisAcT imaging biomarker
- Success rate for collection of paired blood and tissue samples pre and post immunotherapy treatment in each Cohort.
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT03129061 |
40425
ENT0061 |
|
May 1, 2017 |
April 2019 |
June 2019 |
April 26, 2017 |
November 21, 2017 |
|
- Stanford Hospital and Clinics
Stanford, California, United States
|
| 4 |
NCT02139020 |
Recruiting |
Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients |
- Squamous Cell Carcinoma of the Head and Neck
|
|
Observational |
|
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02139020 |
UCL-ONCO 2013-01 |
|
February 2013 |
January 2023 |
January 2023 |
May 15, 2014 |
April 24, 2018 |
|
- Clinique Saint-Pierre
Ottignies, Brabant Wallon, Belgium - Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium - Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize
Haine-Saint-Paul, Belgium - Clinique et Maternité Sainte-Elisabeth
Namur, Belgium
|
| 5 |
NCT02952586 |
Recruiting |
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100) |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Avelumab
- Other: Chemoradiation
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Overall Survival (OS)
- Trough plasma concentration (Ctrough) of avelumab
- (and 16 more...)
|
640 |
All |
18 Years and older (Adult, Senior) |
NCT02952586 |
B9991016
2016-001456-21
LOCALLY ADVANCED HEAD AND NECK |
|
November 28, 2016 |
April 8, 2021 |
May 18, 2022 |
November 2, 2016 |
March 6, 2018 |
|
- Highlands Oncology Group
Fayetteville, Arkansas, United States - Highlands Oncology Group
Rogers, Arkansas, United States - The Oncology Institute of Hope and Innovation
Anaheim, California, United States - (and 286 more...)
|
| 6 |
NCT01360827 |
Terminated |
EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
- Maximum-tolerated-dose (MTD) at 0.32 mg/kg cohort size testing
- Maximum-tolerated-dose (MTD) at 0.48 mg/kg cohort size testing
- (and 3 more...)
|
13 |
All |
18 Years and older (Adult, Senior) |
NCT01360827 |
EMR 200068-007 |
|
August 2010 |
April 2011 |
|
May 26, 2011 |
June 17, 2014 |
|
- Clinical Research Unit and Pharmacology Lab EA 3035 Institut Claudius Regaud
Toulouse, France
|
| 7 |
NCT01737008 |
Completed |
Dacomitinib Plus Radiotherapy, With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: dacomitinib
- Radiation: Radiotherapy
- Drug: Cisplatin
|
Interventional |
Phase 1 |
- University Health Network, Toronto
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (in mg) of Dacomitinib
- To preliminarily evaluate the response rate of the combination of Dacomitinib, Cisplatin and Radiation
- Levels of Dacomitinib in the Blood (Pharmacokinetics) in Combination with Cisplatin and Radiation
- Disease free survival, overall survival and locoregional and distant metastasis free survival
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT01737008 |
XDC-001 |
|
January 2013 |
February 2015 |
May 2015 |
November 29, 2012 |
June 13, 2016 |
|
- Princess Margaret Cancer Centre
Toronto, Ontario, Canada
|
| 8 |
NCT01458392 |
Completed
Has Results |
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR)
- Safety and Tolerability
- Dalantercept Serum Concentration After Single and Multiple Doses
- (and 3 more...)
|
46 |
All |
18 Years and older (Adult, Senior) |
NCT01458392 |
A041-03
dalantercept |
|
October 2011 |
June 2015 |
September 2015 |
October 24, 2011 |
June 27, 2017 |
June 27, 2017 |
- Acceleron Investigative Site
Aurora, Colorado, United States - Acceleron Investigative Site
Atlanta, Georgia, United States - Acceleron Investigative Site
Boston, Massachusetts, United States - (and 5 more...)
|
| 9 |
NCT01040832 |
Completed
Has Results |
EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck Cancer
|
- Drug: Cetuximab
- Drug: EMD 1201081
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS) Time: Independent Read Assessments
- Percentage of Participants With Objective Response: Independent Read Assessments
- Percentage of Participants With Disease Control: Independent Read Assessments
- (and 2 more...)
|
107 |
All |
18 Years and older (Adult, Senior) |
NCT01040832 |
EMR 200068-006 |
|
December 2009 |
January 2012 |
|
December 30, 2009 |
January 30, 2017 |
July 29, 2014 |
- University of Colorado Cancer Center
Aurora, Colorado, United States - University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States - MGH Massachusetts General Hospital
Boston, Massachusetts, United States - (and 32 more...)
|
| 10 |
NCT01528163 |
Completed |
Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cabazitaxel
- Drug: Methotrexate
|
Interventional |
Phase 2 |
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
101 |
All |
18 Years and older (Adult, Senior) |
NCT01528163 |
UCL-ONCO 2011-01
2011-001938-42 |
RACATREX |
February 2012 |
November 2014 |
November 2014 |
February 7, 2012 |
June 14, 2017 |
|
- Clinique Saint-Pierre
Ottignies, Brabant Wallon, Belgium - Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale
Brussels, Bruxelles Capitale, Belgium - RHMS Baudour
Baudour, Hainaut, Belgium - (and 13 more...)
|
| 11 |
NCT01104922 |
Active, not recruiting |
Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Other: Cetuximab and stereotactic radiosurgery
|
Interventional |
Phase 2 |
- Dwight Heron
- University of Pittsburgh
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the 1-year progression-free survival (PFS) of previously irradiated patients with SCCHN treated with radiosurgery and cetuximab;
- To evaluate the acute and late toxicities associated with the above therapy.
|
59 |
All |
18 Years and older (Adult, Senior) |
NCT01104922 |
UPCI 06-093 |
|
July 2007 |
December 2017 |
July 2018 |
April 16, 2010 |
July 25, 2017 |
|
- University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
|
| 12 |
NCT01015664 |
Terminated |
Combination of Cisplatin, Cetuximab and Temsirolimus in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: temsirolimus
- Drug: cisplatin
- Drug: cetuximab
|
Interventional |
Phase 1
Phase 2 |
- University of Tennessee Cancer Institute
- National Comprehensive Cancer Network
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase one - the outcome measure for determining the optimal dose will be determined by whether the subjects experience a dose limiting toxicity (DLT)
- Phase 2 - the outcome measure of Progression-Free Survival is defined as the time from first treatment to the documented progression of disease or death, whichever comes first.
- Overall response rate is defined as the proportion of patients achieving any response (CR + PR) compared to the total patient population.
- (and 2 more...)
|
11 |
All |
18 Years and older (Adult, Senior) |
NCT01015664 |
HN0209 |
|
February 2010 |
December 2012 |
December 2012 |
November 18, 2009 |
December 17, 2012 |
|
- Boston Baskin Caner Foundation
Memphis, Tennessee, United States
|
| 13 |
NCT01012258 |
Completed
Has Results |
Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects |
- Squamous Cell Carcinoma of the Head and Neck
|
- Biological: Cetuximab + concomitant boost radiotherapy
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best Overall Response (BOR)
- Progression-Free Survival (PFS)
|
70 |
All |
18 Years and older (Adult, Senior) |
NCT01012258 |
EMR62241-054 |
CHANCE |
February 2009 |
September 2010 |
May 2014 |
November 13, 2009 |
July 9, 2015 |
August 14, 2012 |
- Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China - Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China - Xiangya Hospital of Central South University
Changsha, Hunan, China - (and 5 more...)
|
| 14 |
NCT02819752 |
Not yet recruiting |
PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
- Squamous Cell Carcinoma
|
- Drug: Pembrolizumab
- Radiation: Radiotherapy
- Drug: Chemotherapy
|
Interventional |
Phase 1 |
- Royal Marsden NHS Foundation Trust
- Institute of Cancer Research, United Kingdom
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- the maximum tolerated dose that can safely be combined with platin-based chemoradiotherapy in patients with HPV-ve and HPV+ve LA-SCCHN
- Acute toxicity as measured during treatment by CTCAE v4.0
- The Progression Free Survival
- (and 3 more...)
|
36 |
All |
18 Years and older (Adult, Senior) |
NCT02819752 |
CCR4325 |
PEACH |
August 2016 |
March 2018 |
December 2018 |
June 30, 2016 |
June 30, 2016 |
|
|
| 15 |
NCT00971932 |
Completed
Has Results |
Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cetuximab
- Drug: Cisplatin/Carboplatin
- Drug: 5-Fluorouracil
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
- Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
- Disease Control Rate
- (and 4 more...)
|
33 |
All |
20 Years and older (Adult, Senior) |
NCT00971932 |
EMR 62241-056 |
|
July 2009 |
March 2011 |
|
September 4, 2009 |
April 8, 2014 |
August 10, 2012 |
- Research Site
Aichi, Japan - National Cancer Center East Hospital
Chiba, Japan - Research Site
Ehime, Japan - (and 7 more...)
|
| 16 |
NCT00442455 |
Completed |
Erlotinib,Radiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Erlotinib chlorhydrate
- Drug: Cisplatin
- Procedure: Radiation therapy
|
Interventional |
Phase 3 |
- Grupo de Investigación Clínica en Oncología Radioterapia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determinate the maximum tolerated dose (PHASE I)
- Progression free survival (PHASE II)
- DLT (PHASE I)
- Overall survival and locoregional progression free survival (PHASE II)
|
53 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00442455 |
ML 18729 |
|
January 2006 |
August 2015 |
August 2015 |
March 2, 2007 |
September 26, 2016 |
|
- Hospital de Navarra
Pamplona, Navarra, Spain - Hospital Clínico San Carlos
Madrid, Spain - Hospital General Universitario Gregorio Marañón
Madrid, Spain - (and 2 more...)
|
| 17 |
NCT01332266 |
Completed |
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck |
- Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
|
- Drug: E7050
- Drug: Cetuximab
|
Interventional |
Phase 1
Phase 2 |
- Eisai Inc.
- PharmaBio Development Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety Parameters- Adverse Events
- Safety Parameter- concomitant medications
- Safety Parameter- Lab tests
- (and 2 more...)
|
95 |
All |
18 Years and older (Adult, Senior) |
NCT01332266 |
E7050-702
2011-000773-31 |
|
May 2011 |
May 2014 |
August 26, 2017 |
April 11, 2011 |
December 15, 2017 |
|
- Tucson, Arizona, United States
- Fort Myers, Florida, United States
- Boston, Massachusetts, United States
- (and 20 more...)
|
| 18 |
NCT01285635 |
Terminated
Has Results |
A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
|
- Drug: AT-101
- Drug: Docetaxel
|
Interventional |
Phase 2 |
- University of Michigan Cancer Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With a Complete Response (CR) and Partial Response (PR)
- Median Duration of Response For All Groups Combined
- Incidence of Grade 3 and 4 Toxicities by Arm
- (and 2 more...)
|
35 |
All |
18 Years and older (Adult, Senior) |
NCT01285635 |
UMCC 2010.031
HUM00040432 |
|
June 2010 |
December 2012 |
September 2015 |
January 28, 2011 |
March 31, 2016 |
July 23, 2015 |
- University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States - Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
|
| 19 |
NCT02158234 |
Recruiting |
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cisplatin
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
|
Interventional |
Phase 1 |
- H. Lee Moffitt Cancer Center and Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT)
- Local Control Rate
- Overall Survival (OS)
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT02158234 |
MCC-17799 |
|
June 3, 2014 |
July 2019 |
July 2020 |
June 6, 2014 |
March 29, 2018 |
|
- H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
|
| 20 |
NCT01830556 |
Unknown † |
Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab in Combination With Paclitaxel and Carboplatin for Treatment of Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
|
Interventional |
Phase 2 |
- Karolinska University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival
- Best overall response
|
120 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01830556 |
CETMET study |
CETMET |
November 2011 |
November 2013 |
November 2015 |
April 12, 2013 |
May 21, 2013 |
|
- Lena Specht
Copenhagen, Denmark - Hedda Haugen
Göteborg, Sweden - Karolinska Universityhospital
Stockholm, Sweden - (and 2 more...)
|
| 21 |
NCT00257738 |
Completed |
0804 GCC: MAGE-A3/HPV 16 Vaccine for Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Biological: MAGE-A3
- Biological: HPV-16 vaccine
|
Interventional |
Phase 1 |
- University of Maryland
- National Institute of Dental and Craniofacial Research (NIDCR)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants experiencing toxicity
- Tumor response
- Tumor infiltrating lymphocytes
|
17 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00257738 |
HP-00041372
R01DE015324 |
|
November 2005 |
October 2012 |
October 2012 |
November 23, 2005 |
February 28, 2018 |
|
- University of Maryland School of Medicine
Baltimore, Maryland, United States
|
| 22 |
NCT03452137 |
Recruiting |
A Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
- Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
|
- Drug: Atezolizumab
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Independent Review Facility assessed Event Free Survival (IRF assessed EFS)
- Overall Survival (OS) after Randomization
- Investigator Assessed Event Free Survival (EFS)
- (and 3 more...)
|
400 |
All |
18 Years and older (Adult, Senior) |
NCT03452137 |
WO40242
2017-003302-40 |
|
April 28, 2018 |
August 28, 2023 |
April 28, 2025 |
March 2, 2018 |
April 17, 2018 |
|
- Southern Cancer Center
Daphne, Alabama, United States - Kaiser Permanente - Bellflower
Bellflower, California, United States - City of Hope National Medical Center
Duarte, California, United States - (and 121 more...)
|
| 23 |
NCT00392665 |
Terminated
Has Results |
Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
|
- Drug: Bevacizumab
- Drug: erlotinib
- Drug: Sulindac
|
Interventional |
Phase 2 |
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Emory University
- (and 3 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.
- Overall Response Rate (ORR)
- Duration of Overall Survival
- Number of Participants With Toxicities According to Severity
|
36 |
All |
18 Years and older (Adult, Senior) |
NCT00392665 |
06-111 |
|
October 2006 |
August 2012 |
December 2013 |
October 26, 2006 |
April 13, 2017 |
March 14, 2017 |
- Massachusetts General Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
| 24 |
NCT02207530 |
Active, not recruiting |
Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
- Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
|
|
Interventional |
Phase 2 |
- AstraZeneca
- PRA Health Sciences
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR)
- Duration of response (DoR)
- Disease control rate (DCR)
- (and 3 more...)
|
112 |
All |
18 Years to 130 Years (Adult, Senior) |
NCT02207530 |
D4193C00001 |
|
October 24, 2014 |
September 26, 2016 |
September 28, 2018 |
August 4, 2014 |
March 23, 2018 |
|
- Research Site
Birmingham, Alabama, United States - Research Site
Yuma, Arizona, United States - Research Site
Duarte, California, United States - (and 105 more...)
|
| 25 |
NCT02624128 |
Recruiting |
Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Valproic Acid
- Drug: Cisplatin
- Drug: Cetuximab
|
Interventional |
Phase 2 |
- National Cancer Institute, Naples
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with an objective response
- overall survival
- time to tumor progression
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
39 |
All |
18 Years and older (Adult, Senior) |
NCT02624128 |
V-CHANCE
2014-001523-69 |
V-CHANCE |
February 2015 |
February 2019 |
October 2019 |
December 8, 2015 |
March 29, 2017 |
|
- Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Italy
|
| 26 |
NCT02543476 |
Completed |
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) |
- Squamous Cell Carcinoma of the Head and Neck
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Prognosis of PD-L1 positive status in the patient population with available tumor sample
- Exposure to risk factors - alcohol (e.g. Number of participants with alcohol consumption and amount of consumption per day)
- Exposure to risk factors - tobacco (e.g. Number of participants with current or past tobacco consumption and amount of consumption per day)
- (and 9 more...)
|
412 |
All |
Child, Adult, Senior |
NCT02543476 |
D4193R00002 |
SUPREME-HN |
September 16, 2015 |
November 14, 2016 |
November 14, 2016 |
September 7, 2015 |
November 14, 2017 |
|
- Research Site
La Jolla, California, United States - Research Site
Atlanta, Georgia, United States - Research Site
Hyattsville, Maryland, United States - (and 15 more...)
|
| 27 |
NCT00627835 |
Withdrawn |
Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) |
- Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
|
- Drug: sorafenib
- Drug: sorafenib and cisplatin
|
Interventional |
Phase 1 |
- British Columbia Cancer Agency
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- To assess the safety of neoadjuvant BAY 43-9006 (sorafenib) and concurrent BAY 43-9006 with radiation in a cohort of SCCHN
- MTD Maximal tolerated dose
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT00627835 |
OZM-003 |
|
|
|
|
March 3, 2008 |
July 20, 2016 |
|
- BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
|
| 28 |
NCT02350712 |
Completed |
Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Patritumab
- Drug: Cetuximab
- Drug: Cisplatin
- Drug: Carboplatin
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of participants experiencing dose-limiting toxicities (DLTs)
- Pharmacokinetic profile of serum patritumab
- Pharmacokinetic profile of serum cetuximab
- (and 2 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT02350712 |
U31287-A-U106 |
|
December 2014 |
March 2016 |
June 2016 |
January 30, 2015 |
April 21, 2017 |
|
- University College London Hospital
London, United Kingdom - The Royal Marsden Hospital
London, United Kingdom - The Royal Marsden Hospital
Surrey, United Kingdom
|
| 29 |
NCT00206219 |
Completed |
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX) |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Gefitinib
- Drug: methotrexate
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Compare ZD1839 versus methotrexate in overall survival
- Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.
|
477 |
All |
18 Years and older (Adult, Senior) |
NCT00206219 |
1839IL/0704
EudraCT no.2004-002662-38 |
|
November 2003 |
September 2007 |
September 2007 |
September 21, 2005 |
January 27, 2011 |
|
- Research Site
Birmingham, Alabama, United States - Research Site
Tucson, Arizona, United States - Research Site
Palm Springs, California, United States - (and 107 more...)
|
| 30 |
NCT00756444 |
Completed
Has Results |
A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck |
- Squamous Cell Carcinoma of Head and Neck
|
- Drug: Panitumumab
- Drug: Cisplatin
- Drug: 5FU
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab
- Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab
|
67 |
All |
18 Years and older (Adult, Senior) |
NCT00756444 |
20080008 |
|
October 2008 |
May 2012 |
May 2012 |
September 22, 2008 |
April 17, 2014 |
December 13, 2013 |
|
| 31 |
NCT03349710 |
Recruiting |
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer |
- Squamous Cell Carcinoma of the Head and Neck
|
- Biological: Nivolumab
- Biological: Cetuximab
- Drug: Placebo
- (and 2 more...)
|
Interventional |
Phase 3 |
- Bristol-Myers Squibb
- ONO Pharmaceutical Co.
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Event Free Survival (EFS)
- Duration of loco-regional control (DLRC)
- Overall Survival (OS)
- (and 3 more...)
|
1046 |
All |
18 Years and older (Adult, Senior) |
NCT03349710 |
CA209-9TM
2017-002676-87 |
|
November 23, 2017 |
November 9, 2022 |
November 10, 2022 |
November 21, 2017 |
April 9, 2018 |
|
- Pinnacle Research Group, Llc
Anniston, Alabama, United States - Cancer Center of Central Connecticut
Plainville, Connecticut, United States - Local Institution
Newark, Delaware, United States - (and 54 more...)
|
| 32 |
NCT03083873 |
Recruiting |
Study of LN-145 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
|
Interventional |
Phase 2 |
- Iovance Biotherapeutics, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate
- Adverse Events
- Complete Response Rate
- (and 4 more...)
|
47 |
All |
18 Years and older (Adult, Senior) |
NCT03083873 |
C-145-03
2016-003446-86 |
|
January 9, 2017 |
October 2018 |
August 2020 |
March 20, 2017 |
April 23, 2018 |
|
- University of California San Diego
La Jolla, California, United States - University of Southern California
Los Angeles, California, United States - Moffitt Cancer Center
Tampa, Florida, United States - (and 7 more...)
|
| 33 |
NCT02882308 |
Recruiting |
Preoperative Administration of Olaparib With or Without Cisplatin in Patients Who Are Candidates for Surgery of Carcinoma of Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Olaparib
- Drug: Cisplatin
|
Interventional |
Phase 2 |
- Hellenic Cooperative Oncology Group
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Investigation of the change between initial and post-treatment Ki67 measured on Formalin- Fixed Parafin-Embedded collected tumour biopsy or surgical sample, before and after treatment with the combination of olaparib + cisplatin or olaparib monotherapy.
- Objective response rate according to RECIST 1.1 criteria
- Pathologic complete response rate
- (and 19 more...)
|
39 |
All |
18 Years and older (Adult, Senior) |
NCT02882308 |
HE5A/15
2015-005268-41 |
OPHELIA |
October 2016 |
December 2017 |
June 2018 |
August 29, 2016 |
October 9, 2017 |
|
- Euromedica General Clinic of Thessaloniki
Thessaloníki, Thessaloniki, Greece - University Hospital "Attikon", 2nd Department of Internal Medicine, Division of Oncology
Athens, Greece
|
| 34 |
NCT02769520 |
Recruiting |
Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Pembrolizumab
- Other: Placebo
|
Interventional |
Phase 2 |
- Ezra Cohen
- 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
|
- Disease-Free Survival at 12 months
- Disease-Free Survival at 2 years
- Overall Survival
- (and 2 more...)
|
45 |
All |
18 Years and older (Adult, Senior) |
NCT02769520 |
151615 |
|
June 2016 |
June 2019 |
June 2020 |
May 11, 2016 |
January 18, 2018 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States - University of California San Francisco
San Francisco, California, United States - University of California Los Angeles
Torrance, California, United States
|
| 35 |
NCT02429089 |
Active, not recruiting |
Study of LEE011plus Cetuximab in Patients With a Cancer of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
|
Interventional |
Phase 1 |
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated dose
- To evaluate the toxicity profile (with CTCAE 4.03 scale)
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT02429089 |
UCL-ONCO 2015-01 |
CETLEE011 |
April 2015 |
September 1, 2017 |
September 1, 2018 |
April 29, 2015 |
April 24, 2018 |
|
- Grand Hôpital de Charleroi site Notre Dame
Charleroi, Hainaut, Belgium - Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, Belgium - Cliniques universitaires Saint-Luc
Brussel, Belgium - (and 2 more...)
|
| 36 |
NCT01177956 |
Completed
Has Results |
A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Biological: Cetuximab
- Drug: Cisplatin
- Drug: 5-Fluorouracil
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best Overall Response (BOR) Until Cut-off Date 25 January 2011
- Best Overall Response (BOR) Until Cut-off Date 15 November 2012
- Overall Survival (OS) Time Until Cut-off Date 15 November 2012
- (and 6 more...)
|
73 |
All |
18 Years and older (Adult, Senior) |
NCT01177956 |
EMR62241_055 |
CHANGE |
December 2009 |
January 2011 |
November 2012 |
August 9, 2010 |
September 3, 2014 |
August 10, 2012 |
- Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, China - Jilin Cancer Hospital
Changchun, China - The Xiangya 2nd Hospital of Central South University
Changsha City, China - (and 11 more...)
|
| 37 |
NCT02707588 |
Active, not recruiting |
Tolerance and Efficacy of Pembrolizumab or Cetuximab Combined With RT in Patients With Locally Advanced HNSCC |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Pembrolizumab
- Drug: Cetuximab
- Radiation: Radiotherapy
|
Interventional |
Phase 2 |
- Groupe Oncologie Radiotherapie Tete et Cou
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Locoregional Control
- Progression free survival
- Locoregional progression and distant metastasis
- (and 7 more...)
|
133 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02707588 |
GORTEC 2015-01 |
PembroRad |
May 2016 |
September 2019 |
June 2020 |
March 14, 2016 |
October 30, 2017 |
|
- Centre Guillaume le conquérant
Le Havre, France
|
| 38 |
NCT02262741 |
Completed |
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer |
- Squamous Cell Carcinoma of the Head and Neck
|
- Biological: MEDI4736
- Biological: tremelimumab
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects reporting adverse events
- Number of subjects reporting serious adverse events
- Number of subjects experiencing dose-limiting toxicities
- (and 14 more...)
|
71 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02262741 |
D4190C00011 |
|
October 15, 2014 |
September 21, 2017 |
September 21, 2017 |
October 13, 2014 |
October 23, 2017 |
|
- Research Site
Scottsdale, Arizona, United States - Research Site
La Jolla, California, United States - Research Site
Los Angeles, California, United States - (and 20 more...)
|
| 39 |
NCT02105636 |
Active, not recruiting
Has Results |
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Nivolumab
- Drug: Cetuximab
- Drug: Methotrexate
- Drug: Docetaxel
|
Interventional |
Phase 3 |
- Bristol-Myers Squibb
- Ono Pharmaceutical Co. Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
- Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR)
|
506 |
All |
18 Years and older (Adult, Senior) |
NCT02105636 |
CA209-141
2013-003622-86 |
|
May 1, 2014 |
November 6, 2015 |
July 27, 2018 |
April 7, 2014 |
November 6, 2017 |
January 11, 2017 |
- Stanford University Medical Center
Palo Alto, California, United States - H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States - Winship Cancer Institute, Emory University
Atlanta, Georgia, United States - (and 61 more...)
|
| 40 |
NCT01333696 |
Unknown † |
Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck |
- Squamous Cell Carcinoma of Head and Neck
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate
- Median progression-free survival
- Median overall survival
|
32 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01333696 |
HNTG 11-01 |
|
April 2011 |
April 2013 |
June 2013 |
April 12, 2011 |
March 5, 2013 |
|
- Fudan University Shanghai Cancer Center
Shanghai, China
|
| 41 |
NCT01783158 |
Completed |
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma |
- Squamous Cell Carcinomas of the Head and Neck
|
- Procedure: Esophagoscopy and chromoendoscopy
|
Observational |
|
- University Hospital Ostrava
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- To detect early synchronous second primary esophageal carcinoma
|
132 |
All |
18 Years to 65 Years (Adult) |
NCT01783158 |
RVO-FNOs/2012 |
HNSCC |
January 2004 |
November 2012 |
December 2012 |
February 4, 2013 |
February 4, 2013 |
|
- University Hospital Ostrava
Ostrava, Czech Republic
|
| 42 |
NCT02022098 |
Active, not recruiting |
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cisplatin
- Radiation: Radiotherapy
- Drug: Debio 1143
- Drug: Placebo
|
Interventional |
Not Applicable |
- Debiopharm International SA
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT)
- Phase II: Complete Response Rate (by RECIST version 1.1) at six months after completion of chemo-radiation therapy (CRT) therapy
- Phase II: Best Overall response rate, Disease Control rate and Response Rate after 10 weeks from the end of CRT
- (and 12 more...)
|
118 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02022098 |
Debio 1143-201 |
|
October 2013 |
December 2018 |
April 2019 |
December 27, 2013 |
March 23, 2018 |
|
- Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF
Lorient, Bp 2233, France - C.H.U. Sud Amiens
Amiens, France - ICO Paul Papin
Angers Cedex 02, France - (and 20 more...)
|
| 43 |
NCT01488318 |
Terminated
Has Results |
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma |
- Squamous Cell Carcinoma Of The Head And Neck
|
- Drug: Cetuximab
- Drug: Dasatinib
|
Interventional |
Phase 2 |
- Julie E. Bauman, MD, MPH
- Bristol-Myers Squibb
- University of Pittsburgh
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR)
- Response to Treatment
- Progression-free Survival (PFS)
- Overall Survival (OS)
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01488318 |
08-034
CA180264 |
|
September 2011 |
January 2016 |
August 2016 |
December 8, 2011 |
January 5, 2018 |
January 5, 2018 |
- University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
|
| 44 |
NCT01386632 |
Active, not recruiting
Has Results |
Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Head and Neck Carcinoma |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: DCA (dichloroacetate)
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Experienced Adverse Events During Treatment.
- Two-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
- Two-year and Five-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
- (and 8 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01386632 |
DCA 2010 |
|
May 2011 |
August 2014 |
January 2019 |
July 1, 2011 |
June 14, 2017 |
June 14, 2017 |
- Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States - Sanford Hematology and Oncology
Sioux Falls, South Dakota, United States
|
| 45 |
NCT01379339 |
Completed |
Cabazitaxel - PF Induction Chemotherapy |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cabazitaxel 10mg/m2
- Drug: Cabazitaxel 12.5mg/m2
- Drug: Cabazitaxel 15mg/m2
- (and 2 more...)
|
Interventional |
Phase 1 |
- Krzysztof Misiukiewicz
- Sanofi
- Icahn School of Medicine at Mount Sinai
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD)
- Dose-limiting toxicity (DLT)
- Toxicity Profile
- (and 2 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT01379339 |
11-0646(0001)(01)
183133-96-2
HS#: 11-00201 |
|
April 2011 |
January 2015 |
January 2015 |
June 23, 2011 |
February 11, 2015 |
|
- Icahn School of Medicine at Mount Sinai
New York, New York, United States
|
| 46 |
NCT02054442 |
Recruiting |
A Study of the Combination of Cetuximab and Methotrexate in Recurrent or Metastatic Cancer of the Head and Neck |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cetuximab
- Drug: Methotrexate
|
Interventional |
Phase 1
Phase 2 |
- Radboud University
- Merck Serono International SA
- Leiden University Medical Center
- (and 6 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of dose limiting toxicity (DLT)
- Progression free survival
- Overall survival (OS)
- Response rate (RR)
|
51 |
All |
18 Years and older (Adult, Senior) |
NCT02054442 |
MOHN01
2013-002886-20
DHNS 2013-01 |
COMMENCE |
August 2016 |
November 2017 |
February 2018 |
February 4, 2014 |
June 1, 2017 |
|
- Medical Centre Haaglanden
Den Haag, Netherlands - Medisch Spectrum Twente
Enschede, Netherlands - Medical Centre Leeuwarden
Leeuwarden, Netherlands - (and 5 more...)
|
| 47 |
NCT01064479 |
Active, not recruiting |
Docetaxel And Cisplatin With or Without Erlotinib For Metastatic Or Recurrent Squamous Cell Carcinoma Of Head And Neck |
- Head and Neck Cancer
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Cisplatin
- Drug: Docetaxel
- Drug: Erlotinib
- (and 2 more...)
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- OSI Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Median Progression Free Survival (PFS)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT01064479 |
2009-0395
NCI-2011-03782 |
|
February 2010 |
February 2019 |
February 2019 |
February 8, 2010 |
August 2, 2017 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
| 48 |
NCT01051791 |
Terminated
Has Results |
Phase II Study of RAD001 Head and Neck Cancer |
- Squamous Cell Carcinoma of the Head and Neck
|
- Drug: Everolimus 10mg daily
|
Interventional |
Phase 2 |
- Julie E. Bauman, MD, MPH
- Novartis
- University of Pittsburgh
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Benefit Rate (CBR)
- Progression Free Survival (PFS)
- Overall Survival (OS)
- Objective Response Rate (ORR)
|
13 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01051791 |
08-032 |
|
January 2010 |
April 26, 2011 |
August 5, 2016 |
January 20, 2010 |
December 19, 2017 |
December 19, 2017 |
- Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
|
| 49 |
NCT00652613 |
Unknown † |
Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) Versus Intensity Modulated Radiotherapy (IMRT) for Head and Neck Squamous Cell Carcinoma (HNSCC) |
- Squamous Cell Carcinoma of the Head and Neck
|
- Radiation: 3 Dimensional Radiation Therapy
- Radiation: Intensity Modulated Radiation Therapy
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Major salivary gland sparing by 3-D CRT vis-à-vis IMRT. Assess adequacy of target volume coverage
- Determine the pattern of local and loco-regional recurrence
- Disease Free Survival (DFS) and Overall Survival (OAS)
- (and 2 more...)
|
60 |
All |
18 Years to 65 Years (Adult) |
NCT00652613 |
H&N_3DCRT_IMRT07 |
|
August 2005 |
March 2008 |
August 2009 |
April 4, 2008 |
April 11, 2008 |
|
- Tata Memorial Hospital
Mumbai, Maharashtra, India
|
| 50 |
NCT03139058 |
Not yet recruiting |
Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck |
- Liver Fibroses
- Liver Cirrhoses
- Squamous Cell Carcinoma of the Head and Neck
|
- Other: Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire, Amiens
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03139058 |
PI2016_843_0034 |
fibr'HOM |
August 20, 2017 |
June 20, 2019 |
June 20, 2019 |
May 3, 2017 |
July 21, 2017 |
|
- CHU Amiens Picardie
Amiens, Picardie, France
|
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