Head and Neck Cancer Clinical Trial
Official title:
Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck
Verified date | November 2014 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in
treating patients with stage IV cancer of the head and neck.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2005 |
Est. primary completion date | March 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity,
oropharynx, hypopharynx, or larynx No distant metastatic disease No previous or concurrent
head and neck primaries No lip, nasopharynx, or salivary gland lesions No recurrent tumors
Stage IV disease comprised of T4 NO-3 lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky greater than 60 Life Expectancy: Not specified Hematopoietic: ANC greater than 2,000 Platelet count greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: Not specified Other: Not pregnant or nursing No adverse medical illnesses No imaging studies performed greater than one month preregistration No laboratory studies greater than 2 weeks preregistration No other malignancies, except for basal or squamous cell of the skin, within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No prior surgery to study site other than a biopsy Other: Protocol treatment must begin within 8 weeks of biopsy |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Fletcher-Allen Health Care | Burlington | Vermont |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | University of California San Diego Cancer Center | La Jolla | California |
United States | CCOP - Baptist Cancer Institute | Memphis | Tennessee |
United States | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee |
United States | Vanderbilt Cancer Center | Nashville | Tennessee |
United States | MBCCOP - LSU Medical Center | New Orleans | Louisiana |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Green Mountain Oncology Group | Rutland | Vermont |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | University Cancer Center | Seattle | Washington |
United States | University of Washington Neutron Facility and Cancer Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States,
Kumar P, Harris J, Garden AS, et al.: Outcome comparisons of four Radiation Therapy Oncology Group (RTOG) trials in patients with stage IV-T4 head and neck (H/N) cancer: encouraging results using intra-arterial (IA) cisplatin (P) and concurrent radiation therapy (RT). [Abstract] J Clin Oncol 22 (Suppl 14): A-5527, 494s, 2004.
Kumar P, Harris J, Robbins KT, et al.: The feasibility of using intra-arterial cisplatin & radiation therapy for stage IV-T4 head/neck squamous cell carcinoma in a multi-institutional setting: preliminary results of Radiation Therapy Oncology Group (RTOG)
Kumar P, Robbins KT, Harris J, et al.: Intra-arterial (IA) cisplatin (P) and radiation therapy (RT) is feasible in a multi-institutional setting for the treatment of stage IV-T4 head/neck (H/N) squamous cell carcinoma (SCCa): initial results of Radiation
Kumar P, Robbins KT, Harris J, et al.: Mature results of Radiation Therapy Oncology Group (RTOG) trial 9615 using intra-arterial cisplatin (IA-P) and concurrent radiation therapy (RT) for stage IV-T4 head/neck (H/N) squamous cell carcinoma (SCCa). [Abstra
Robbins KT, Kumar P, Harris J, McCulloch T, Cmelak A, Sofferman R, Levine P, Weisman R, Wilson W, Weymuller E, Fu K. Supradose intra-arterial cisplatin and concurrent radiation therapy for the treatment of stage IV head and neck squamous cell carcinoma is — View Citation
Targeted chemoradiation (RTOG 96-15) (RADPLAT) for T4 carcinoma of the upper aerodigestive tract: interim analysis of a multi-institutional trial. [Abstract] Proceedings of the International Conference on Head and Neck Cancer A046, 78, 2000.
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |