|Phase II||Treatment||Completed||Not specified||NCI, Other||RTOG-9904|
CDR0000067026, RTOG-DEV-1046, NCT00003862
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.
Further Study Information
- 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.
- 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
- Not specified
- Zubrod 0-2
- At least 16 weeks
- Absolute granulocyte count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine less than 1.5 mg/dL
- No New York Heart Association class III or IV heart disease
- No hypertension
- No cerebrovascular disease
- No diabetic neuropathy
- No mental status abnormalities
- 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:
- No prior immunotherapy
- No prior chemotherapy
- Not specified
- No prior radiotherapy to stomach
- No prior surgery to stomach
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology GroupNational Cancer Institute
|Jaffer A. Ajani||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003862
ClinicalTrials.gov processed this data on October 17, 2013
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