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)
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Mount Holly, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Fox Chase Cancer Center at St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Lutheran General Hospital Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Northridge Hospital Medical Center
🇺🇸Northridge, California, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
🇺🇸Greenville, North Carolina, United States
Wayne Memorial Hospital, Inc.
🇺🇸Goldsboro, North Carolina, United States
Ball Memorial Hospital Cancer Center
🇺🇸Muncie, Indiana, United States
Porter Memorial Hospital
🇺🇸Valparaiso, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Penrose - St. Francis Health Services
🇺🇸Colorado Springs, Colorado, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
Presbyterian-St Luke's Medical Center
🇺🇸Denver, Colorado, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Norris Cotton Cancer Center at Dartmouth Medical School
🇺🇸Lebanon, New Hampshire, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States