Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease
OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage
IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to
treatment with subtotal nodal irradiation with vs. without 3 courses of
doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these
treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility.
III. Identify subgroups of patients (based on age, gender, tumor histology, number of
disease sites, and presence of high neck presentation) that are particularly responsive to
these treatments.
OUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage
equipment (4-10 MeV). Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy.
Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal
irradiation as in Arm I.
PROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival
every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
No
Oliver W. Press, MD, PhD
Study Chair
University of Washington
United States: Federal Government
CDR0000077691
NCT00002495
September 1992
May 2015
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |