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Phase III Randomized Comparison of Involved-Field vs Extended-Field Radiotherapy in Combination with ABVD (DOX/BLEO/VBL/DTIC) in Patients with Bulky Early-Stage Hodgkin's Disease (Summary Last Modified 05/92)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Closed any age MSKCC-91069
NCI-V91-0178

Objectives

I.  Determine the optimal extent of the radiation field in a combined modality 
program with ABVD (doxorubicin/bleomycin/vinblastine/dacarbazine) for bulky 
Hodgkin's disease.

II.  Evaluate the efficacy and toxicity of this combined modality program with 
a reduced potential for leukemogenesis and sterility in these patients.

Entry Criteria

Disease Characteristics:


Previously untreated bulky Hodgkin's disease

Bulky disease defined as clinical or pathological stage
IA/IB/IIA/IIB/IIIA with or without E lesions with at least 1 of
the following:

  Mediastinal mass more than one-third the thoracic diameter on
  chest x-ray

  Node or nodal mass at least 10 cm in diameter

Histological confirmation by MSKCC required

Prior/Concurrent Therapy:


No prior therapy

Patient Characteristics:


Age:
  Any age

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No pregnant women

Expected Enrollment

A total of 180 patients (90 per arm) will be entered over 6 years.

Outline

Randomized study.  Patients are randomized prior to treatment on Regimen A and 
begin treatment on Arm I or II 4 weeks after completion of chemotherapy.

Regimen A:  ABVD:  Doxorubicin, DOX, NSC-123127; Bleomycin, BLEO, NSC-125066; 
Vinblastine, VBL, NSC-49842; Dacarbazine, DTIC, NSC-45388.

Arm I:  Radiotherapy.  Involved-field irradiation (equipment not specified).

Arm II:  Radiotherapy.  Extended-field irradiation (equipment not specified).

Published Results

Hirsch A, Vander Els N, Straus DJ, et al.: Effect of ABVD chemotherapy with and without mantle or mediastinal irradiation on pulmonary function and symptoms in early-stage Hodgkin's disease. J Clin Oncol 14 (4): 1297-305, 1996.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Joachim Yahalom, MD, Protocol chair
Ph: 212-639-5999; 800-525-2225
Email: yahalomj@mskcc.org

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.