SWOG-9451, Combination Chemo & RT For Patients With Stage III/Stage IV Cancer of the Hypopharynx or Tongue
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: Induction chemotherapyRadiation: low-LET cobalt-60 gamma ray therapy
- Registration Number
- NCT00002735
- Lead Sponsor
- SWOG Cancer Research Network
- 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue.
- Detailed Description
OBJECTIVES: I. Determine the complete histologic response rate (which represents the rate of organ preservation) to induction with cisplatin/fluorouracil followed by radiotherapy plus cisplatin in patients with selected stage III/IV cancer of the hypopharynx or base of the tongue. II. Evaluate the feasibility of accruing and treating patients with this regimen in a multi-institutional setting. III. Determine the overall complete response rate in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to center and tumor site (hypopharynx vs base of tongue). Base of tongue stratum closed as of November 15, 1998. Regimen A: Patients receive cisplatin IV over 90 minutes on days 1 and 22 and fluorouracil IV over 120 minutes on days 1-5 and 22-26. Patients with measurable neck nodes discontinue therapy if disease has progressed by day 22. All patients who achieve complete or partial response at day 43 proceed to regimen B. All others proceed to resection followed by radiotherapy (off study). Regimen B (begins within 3-4 weeks of start of second induction course): Patients receive cisplatin IV over 90 minutes every 3 weeks for 3 courses. Concurrently, patients receive radiotherapy 5 days a week for 5.6 weeks. Patients are reassessed at 8-12 weeks after radiotherapy. Patients who are disease free are observed. Other patients undergo surgical resection of nodes and/or primary tumor. Patients are followed every 4-6 weeks for 1 year, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, then annually thereafter.
PROJECTED ACCRUAL: Up to 70 patients (35/tumor site) will be accrued for this study over 3.5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm fluorouracil induction chemotherapy followed by chemoradiation Treatment arm Induction chemotherapy induction chemotherapy followed by chemoradiation Treatment arm low-LET cobalt-60 gamma ray therapy induction chemotherapy followed by chemoradiation Treatment arm cisplatin induction chemotherapy followed by chemoradiation
- Primary Outcome Measures
Name Time Method Complete response 23 to 27 weeks after beginning treatment Complete disappearance of all measurable and evaluable disease. No new lesions, No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. Specifically, the rate of organ preservation (no surgery required at the primary tumor site).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States