Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial]

EORTC-20931

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.

1993-09-01

1998-10-01

Early phase I

1158

DISEASE CHARACTERISTICS: * Histologically confirmed supradiaphragmatic Hodgkin's lymphoma * Stage I or II disease * Previously untreated disease PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Normal life expectancy * No severe cardiac, pulmonary, neurologic, or metabolic disease that would interfere with normal life expectancy or study treatment * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No psychological, familial, socioeconomic, or geographic circumstance that would preclude proper staging or study compliance * HIV negative * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior staging laparotomy * No prior biologic therapy, chemotherapy, endocrine therapy, radiotherapy, or surgery for this malignancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 1158, 'type': 'ESTIMATED'}}

2024-02-22