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

Phase 3

Active, not recruiting

• Conditions: Lymphoma

• Registration Number: NCT00002462
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Study Timeline

• Study First Submitted: 1999-11-01
• Primary Completion: 2000-05
• Study First Submitted QC: 2004-07-23
• Study First Posted: 2004-07-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT
Efficacy of MOPP/ABV hybrid CT

Secondary Outcome Measures

Name	Time	Method
Relapse free survival
Overall survival

Trial Locations

Locations (56)

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

A.Z. St. Jan; 🇧🇪 Brugge, Belgium

C.H.U. Saint-Pierre; 🇧🇪 Brussels (Bruxelles), Belgium

Institut Jules Bordet; 🇧🇪 Brussels (Bruxelles), Belgium

Centre Hospitalier Universitaire Brugmann; 🇧🇪 Brussels (Bruxelles), Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Centre Hospitalier Universitaire de Tivoli; 🇧🇪 La Louviere, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

U.Z. Sint-Rafael; 🇧🇪 Leuven, Belgium

National Cancer Institute of Egypt; 🇪🇬 Cairo, Egypt

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