A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
OBJECTIVES:
- Compare the 2-year disease-free survival in patients with resected stage IB-IIIB
gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without
fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116
(RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)
- Compare the safety and success of these regimens vs therapy in the intergroup adjuvant
study.
- Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the
intergroup study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more).
Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of
6/18/03.)
- Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously
and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on
days 1 and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and
fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also
receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
- Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on
days 1 and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and
paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive
cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
David Paul Kelsen, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000068464
NCT00011960
May 2001
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
Baptist Hospital of Miami | Miami, Florida 33176-2197 |
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
John F. Kennedy Medical Center | Edison, New Jersey 08818 |
Community Medical Center | Toms River, New Jersey 08755 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
Akron General Medical Center | Akron, Ohio 44302 |
CCOP - Dayton | Kettering, Ohio 45429 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
Columbia Hospital | Milwaukee, Wisconsin 53211 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey 08060 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Pocono Cancer Center | East Stroudsburg, Pennsylvania 18301 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Cancer Center at Lexington Clinic | Lexington, Kentucky 40504 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
St. Charles Hospital | Oregon, Ohio 43616 |
Medical College of Ohio Cancer Institute | Toledo, Ohio 43614 |
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
Flower Hospital - ProMedica Health System | Sylvania, Ohio 43560 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Wayne Memorial Hospital, Inc. | Goldsboro, North Carolina 27533 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Alexian Brothers Cancer Care Center | Elk Grove Village, Illinois 60007 |
Akron City Hospital - Summa Health System | Akron, Ohio 44304 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |