Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: paclitaxel
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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: Age: 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 Hepatic: 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 Renal: 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 Other: 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 Surgery: See Disease Characteristics Other: No other concurrent anticancer therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: paclitaxel|nan|
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus