Trial Information

Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease

OBJECTIVES: I. Compare relapse-free survival and overall survival of patients with Stage
III/IV Hodgkin's disease randomly assigned to adjuvant involved-field radiotherapy vs. no
adjuvant therapy following remission induction with MOPP/ABV (nitrogen
mustard/vincristine/procarbazine/prednisone/doxorubicin/bleomycin/vinblastine). II. Evaluate
the therapeutic efficacy of MOPP/ABV hybrid chemotherapy in advanced Hodgkin's disease. III.
Evaluate the prognostic significance of an early response to MOPP/ABV in patients with
advanced Hodgkin's disease.

OUTLINE: Study randomized for adjuvant radiotherapy. All patients receive Induction
chemotherapy on Regimen A, following which those in CR are randomized on Arms I and II.
Regimen A: 7-Drug Combination Chemotherapy. MOPP/ABV Hybrid. Mechlorethamine, NM, NSC-762;
Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023;
Doxorubicin, DOX, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842. Arm
I: Radiotherapy. Involved-field irradiation using megavoltage equipment. Arm II: No further
therapy.

PROJECTED ACCRUAL: 321 evaluable patients will be required; an annual accrual rate of 80
patients is anticipated.