Gastric Cancer
Conditions
Keywords
stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
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 chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.
Detailed description
OBJECTIVES: * Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach. * Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen. * Determine the tolerability of this regimen in these patients. OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29. Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29. Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection. Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter. PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.
Interventions
DRUGcisplatin
DRUGfluorouracil
DRUGleucovorin calcium
DRUGpaclitaxel
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma of the stomach * Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0) * No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes) * Potentially resectable * May involve the gastroesophageal junction, but bulk of tumor must be in the stomach * No distant metastases * No pleural or pericardial effusion * No peritoneal disease diagnosed by laparoscopy PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * At least 16 weeks Hematopoietic: * Absolute granulocyte count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease * No hypertension Neurologic: * No cerebrovascular disease * No diabetic neuropathy * No mental status abnormalities Other: * No uncontrolled diabetes * No infection * No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to stomach Surgery: * No prior surgery to stomach
Countries
United States
Outcome results
None listed