Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00002932
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. II. Determine the partial and complete response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and overall survival in these patients. V. Determine the incidence and pattern of recurrence in these patients. VI. Document quality of life measured by disease-specific instruments in these patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
Green Mountain Oncology Group
🇺🇸Rutland, Vermont, United States
University of Washington Neutron Facility and Cancer Center
🇺🇸Seattle, Washington, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
University Cancer Center
🇺🇸Seattle, Washington, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, 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
Fletcher-Allen Health Care
🇺🇸Burlington, Vermont, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States