Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
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 after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 824 patients will be accrued for this study.
Required Tumor Parameters
1.1 Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
1.2 Patients must have had en bloc resection of all known tumor. The surgical resection must have been done with a curative intent.
1.3 Patients must have tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease.
1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of tumor at the distal or proximal line of stomach resection, noncontiguous resection of tumor, or M1 (metastatic) disease are ineligible.
Prior Therapy
2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years.
2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.
Patient Characteristics
3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2.
3.2 Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical body weight. Patients must have documentation of stable weight (or less than 2 pounds weight loss) for at least one week prior to registration.
3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to ensure that the patient is an appropriate candidate for radiation therapy.
3.4 Patients may not have unilateral renal function (only one functioning kidney) as determined by CT scan with contrast, urogram, renal scan, or other study.
3.5 Pregnant or lactating women may not participate. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method or practice abstinence while in this study.
3.6 Patients with any of the following cardiac conditions are ineligible:
3.7 No uncontrolled serious medical or psychiatric illness which would prevent compliance with treatment or adequate informed consent.
3.8 Patients with active infectious process are ineligible.
3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.
Required Initial Laboratory Values:
Tucson, Arizona 85724-5024, United States
Fort Smith, Arkansas 72903, United States
Jonesboro, Arkansas 72401-9320, United States
Little Rock, Arkansas 72205, United States
Monterey, California 93940, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06102-5037, United States
Washington D.C., District of Columbia 20007, United States
Boca Raton, Florida 33486, United States
Fort Lauderdale, Florida 33308, United States
Pensacola, Florida 32514, United States
Savannah, Georgia 31403-3089, United States
Savannah, Georgia 31405, United States
Boise, Idaho 83712, United States
Chicago, Illinois 60611-3013, United States
Chicago, Illinois 60657, United States
Libertyville, Illinois 60048, United States
Maywood, Illinois 60153, United States
Olympia Fields, Illinois 60461, United States
Beech Grove, Indiana 46107, United States
Indianapolis, Indiana 46202-5289, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
West Des Moines, Iowa 50266, United States
Wichita, Kansas 67214, United States
Baltimore, Maryland 21201, United States
Baltimore, Maryland 21231-2410, United States
Rockville, Maryland 20878, United States
Boston, Massachusetts 02115, United States
Fall River, Massachusetts 02721, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Columbia, Missouri 65203, United States
St Louis, Missouri 63141, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Marlton, New Jersey 08053, United States
Morristown, New Jersey 07962, United States
New Brunswick, New Jersey 08903, United States
Vineland, New Jersey 08360, United States
Voorhees Township, New Jersey 08043, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Rochester, New York 14642, United States
Staten Island, New York 10305, United States
The Bronx, New York 10466, United States
Chapel Hill, North Carolina 27599-7295, United States
Charlotte, North Carolina 28232-2861, United States
Charlotte, North Carolina 28233-3549, United States
Pinehurst, North Carolina 28374, United States
Winston-Salem, North Carolina 27157-1096, United States
Columbus, Ohio 43210-1240, United States
Salem, Ohio 44460, United States
Allentown, Pennsylvania 18105, United States
DuBois, Pennsylvania 15801, United States
East Stroudsburg, Pennsylvania 18301, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19104-4283, United States
Philadelphia, Pennsylvania 19107-5541, United States
Scranton, Pennsylvania 18508, United States
Wilkes-Barre, Pennsylvania 18711, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States
Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195-6043, United States
Charleston, West Virginia 25304, United States
Huntington, West Virginia 25701, United States
Parkersburg, West Virginia 26102, United States
Green Bay, Wisconsin 54301-3526, United States