A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 138
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor
- •No more than 8 weeks since primary tumor resection
- •No metastatic disease
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC (white blood cell count) at least 4,000/mm^3
- •Platelet count at least 150,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal
- •BUN(blood urea nitrogen)less than 30 mg/dL
- •Creatinine no greater than 1.4 mg/dL
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No active angina or myocardial infarction within the past 6 months
- •No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
- •No history of clinically significant conduction system abnormality
- •No concurrent serious infection that is uncontrolled or would preclude study participation
- •No nonmalignant medical illness that is uncontrolled or would preclude study participation
- •No psychiatric disorders that would preclude study participation
- •No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No clinically significant hearing loss
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to the treatment field
- •See Disease Characteristics
- •No other concurrent anticancer therapy
排除标准
- 未提供