Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
- Conditions
- Gastric CancerEsophageal Cancer
- Registration Number
- NCT00011960
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.
- Detailed Description
OBJECTIVES:
* Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)
* Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study.
* Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)
* Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
* Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Related Research Topics
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Trial Locations
- Locations (69)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Scroll for more (59 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States