A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease
A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to number of adverse risk factors (0-2 vs 3-7), disease characteristics (locally extensive vs advanced) and time of entry (before addendum 6 vs. after addendum 6). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study within 4.3 years.
Inclusion criteria:
Histologically proven previously untreated classical Hodgkin's lymphoma
The following stages are eligible:
Measurable or evaluable disease
Age of 16 and over
ECOG Performance status 0-2
Disease-free of prior invasive malignancies for >5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)
Platelet count at least 100,000/mm³ (unless documented bone marrow involvement)
Bilirubin no greater than 5.0 mg/dL
Creatinine no greater than 2.0 mg/dL
Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease
Fertile patients must use effective contraception
Prior corticosteroids allowed
Prior surgery allowed
Exclusion criteria:
Tucson, Arizona 85724-5024, United States
Oakland, California 94602, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Washington D.C., District of Columbia 20007, United States
Fort Lauderdale, Florida 33308, United States
Savannah, Georgia 31403-3089, United States
Boise, Idaho 83706, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Maywood, Illinois 60153, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Skokie, Illinois 60076, United States
Beech Grove, Indiana 46107, 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
Kansas City, Kansas 66160-7357, United States
Wichita, Kansas 67214, United States
Louisville, Kentucky 40202, United States
Shreveport, Louisiana 71130-3932, United States
Baltimore, Maryland 21201, United States
Baltimore, Maryland 21231-2410, United States
Springfield, Massachusetts 01199, United States
Ann Arbor, Michigan 48106-0995, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Lambertville, Michigan 48144, United States
Saint Joseph, Michigan 49085, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Cape Girardeau, Missouri 63701, United States
Columbia, Missouri 65203, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Grand Island, Nebraska 68803, United States
Omaha, Nebraska 68198-6805, United States
Keene, New Hampshire 03431, United States
Lebanon, New Hampshire 03756-0002, United States
Morristown, New Jersey 07962, United States
New Brunswick, New Jersey 08903, United States
Voorhees Township, New Jersey 08043, United States
Voorhees Township, New Jersey 08043, United States
Albuquerque, New Mexico 87131-5636, United States
Rochester, New York 14642, United States
The Bronx, New York 10461, United States
The Bronx, New York 10466, United States
Chapel Hill, North Carolina 27599-7295, United States
Charlotte, North Carolina 28232-2861, United States
Greenville, North Carolina 27835-6028, United States
Winston-Salem, North Carolina 27103, United States
Winston-Salem, North Carolina 27157-1096, United States
Columbus, Ohio 43210-1240, United States
Westerville, Ohio 43081, United States
Portland, Oregon 97210, United States
Portland, Oregon 97213-2967, United States
Portland, Oregon 97227, United States
Allentown, Pennsylvania 18105, United States
Drexel Hill, Pennsylvania 19026, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19104-4283, United States
Charleston, South Carolina 29425, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States
Knoxville, Tennessee 37901, United States
San Antonio, Texas 78229-3900, United States
Burlington, Vermont 05401, United States
Richmond, Virginia 23298-0037, United States
Seattle, Washington 98114, United States
Seattle, Washington 98195-6043, United States
Yakima, Washington 98902, United States
Charleston, West Virginia 25304, United States
Morgantown, West Virginia 26506, United States
La Crosse, Wisconsin 54601, United States
Manitowoc, Wisconsin 54221-1450, United States
Thunder Bay, Ontario P7B 6V4, Canada
Toronto, Ontario M4N 3M5, Canada