NCT00002462

RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate
DRUG	doxorubicin hydrochloride
DRUG	mechlorethamine hydrochloride
DRUG	prednisone
DRUG	procarbazine hydrochloride
DRUG	vinblastine sulfate
DRUG	vincristine sulfate
RADIATION	low-LET cobalt-60 gamma ray therapy
RADIATION	low-LET photon therapy
RADIATION	radiation therapy

Timeline

• Start date: 1989-09-01
• Primary completion: 2000-05-01
• First posted: 2004-07-26
• Last updated: 2025-08-05

Locations

56 sites across 9 countries: Belgium, Egypt, France, Germany, Italy, Netherlands, Poland, Portugal, Slovenia