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

Phase 3Active Not RecruitingNCT00002462

European Organisation for Research and Treatment of Cancer - EORTC615 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

615

Conditions

Lymphoma

Interventions

bleomycin sulfateBIOLOGICAL

doxorubicin hydrochlorideDRUG

mechlorethamine hydrochlorideDRUG

prednisoneDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 70 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: Histologically proven clinical or pathological Stage III/IV Hodgkin's disease Pathological Stage IIIAS disease with the spleen as the only site of subdiaphragmatic involvement excluded PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: Not specified Life expectancy: No severe limits on life expectancy due to nonmalignant disease Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease that would preclude protocol therapy Pulmonary: No severe pulmonary disease that would preclude protocol therapy Other: No severe metabolic or neurologic disease that would preclude protocol therapy No concomitant or previous second malignancy except: Nonmelanomatous skin cancer In situ carcinoma of the cervix PRIOR CONCURRENT THERAPY: No prior therapy

Locations (56)

Outcomes

Primary Outcomes

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

Efficacy of MOPP/ABV hybrid CT

Secondary Outcomes

Relapse free survival

Overall survival

Data from ClinicalTrials.gov

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Algemeen Ziekenhuis Middelheim

Antwerp, Belgium

A.Z. St. Jan

Bruges, Belgium

Hopital Universitaire Erasme

Brussels, Belgium

C.H.U. Saint-Pierre

Brussels (Bruxelles), Belgium

Institut Jules Bordet

Brussels (Bruxelles), Belgium

Centre Hospitalier Universitaire Brugmann

Brussels (Bruxelles), Belgium

Centre Hospitalier Universitaire de Tivoli

La Louvière, Belgium

U.Z. Gasthuisberg

Leuven, Belgium

U.Z. Sint-Rafael

Leuven, Belgium

National Cancer Institute of Egypt

Cairo, Egypt

...and 46 more locations