A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Jaffer A. Ajani, MD
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
CDR0000067026
NCT00003862
November 1999
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Mount Diablo Medical Center | Concord, California 94524-4110 |
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
McLaren Regional Cancer Center | Flint, Michigan 48432 |
CCOP - Dayton | Kettering, Ohio 45429 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Harrington Cancer Center | Amarillo, Texas 79106 |
LDS Hospital | Salt Lake City, Utah 84143 |
Columbia Hospital | Milwaukee, Wisconsin 53211 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Presbyterian-St Luke's Medical Center | Denver, Colorado 80218 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Greenville Hospital System | Greenville, South Carolina 29605 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey 08060 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville, North Carolina 27858-4354 |
Norris Cotton Cancer Center at Dartmouth Medical School | Lebanon, New Hampshire 03756-0002 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey 08629 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Northridge Hospital Medical Center | Northridge, California 91328 |
Penrose - St. Francis Health Services | Colorado Springs, Colorado 80933 |
Lutheran General Hospital Cancer Care Center | Park Ridge, Illinois 60068 |
Ball Memorial Hospital Cancer Center | Muncie, Indiana 47303-3499 |
Porter Memorial Hospital | Valparaiso, Indiana 46383 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wayne Memorial Hospital, Inc. | Goldsboro, North Carolina 27533 |