Spots Global Cancer Trial Database for Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
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Trial Identification
Brief Title: Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
Official Title: A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
Study ID: NCT00003862
Conditions
Study Description
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.
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Lutheran General Hospital Cancer Care Center, Park Ridge, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, 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
McLaren Regional Cancer Center, Flint, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon, New Hampshire, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital, Mount Holly, 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
Wayne Memorial Hospital, Inc., Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina, Greenville, North Carolina, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, 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
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
Greenville Hospital System, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Harrington Cancer Center, Amarillo, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
University of Washington Medical Center, Seattle, Washington, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Columbia Hospital, Milwaukee, Wisconsin, United States
Contact Details
Name: Jaffer A. Ajani, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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