Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT00003862
- Lead Sponsor
- Radiation Therapy Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Northridge Hospital Medical Center
🇺🇸Northridge, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Penrose - St. Francis Health Services
🇺🇸Colorado Springs, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Presbyterian-St Luke's Medical Center
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Scroll for more (45 remaining)Providence Alaska Medical Center🇺🇸Anchorage, Alaska, United States