Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck
NCT ID: NCT00002932
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
1997-05-31
2005-03-31
Brief Summary
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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.
Detailed Description
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OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure.
PROJECTED ACCRUAL: 60 patients will be enrolled.
Conditions
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Study Design
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TREATMENT
Interventions
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cisplatin
radiation therapy
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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K. Thomas Robbins, MD
Role: STUDY_CHAIR
University of Florida
Locations
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University of California San Diego Cancer Center
La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 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
Fletcher-Allen Health Care
Burlington, Vermont, United States
Green Mountain Oncology Group
Rutland, Vermont, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
University Cancer Center
Seattle, Washington, United States
University of Washington Neutron Facility and Cancer Center
Seattle, Washington, United States
Countries
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References
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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.
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 feasible and efficacious in a multi-institutional setting: results of Radiation Therapy Oncology Group Trial 9615. J Clin Oncol. 2005 Mar 1;23(7):1447-54. doi: 10.1200/JCO.2005.03.168.
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.
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) trial 9615. Int J Radiat Oncol Biol Phys 48(3 suppl): A-81, 152, 2000.
Other Identifiers
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CDR0000065366
Identifier Type: -
Identifier Source: secondary_id
RTOG-9615
Identifier Type: -
Identifier Source: org_study_id