A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
cisplatin
+ fluorouracil
+ leucovorin calcium
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 55 locations
Providence Alaska Medical Center
Anchorage, United StatesOpen Providence Alaska Medical Center in Google MapsFoundation for Cancer Research and Education
Phoenix, United StatesMount Diablo Medical Center
Concord, United StatesNorthridge Hospital Medical Center
Northridge, United States