Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Combination Chemotherapy With or Without Radiation Therapy in Patients with Advanced Hodgkin's Disease

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	14 and over	Other	SAFR-CT-HD-2

Objectives

I.  Compare ChlVPP (chlorambucil/vinblastine/procarbazine/prednisone) with vs. 
without radiotherapy to involved lymph node areas in patients with responding 
advanced Hodgkin's disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 14 years of age 
with pathological Stage IIIB/IV Hodgkin's disease and those over age 55 with 
any stage disease.  Disease histology must be confirmed by cytochemistry, 
membrane surface markers, and ultrastructure studies.

Expected Enrollment

Not given.

Outline

Randomized study.  All patients are nonrandomly assigned to 3 courses of 
ChlVPP on Regimen A.  Responding patients are randomized on Arms I and II, 
while nonresponders proceed to Regimen B.  Patients responding to treatment on 
Regimen B are randomized on Arms III and IV; nonresponders receive salvage 
therapy on Regimen C.
Regimen A:  4-Drug Combination Chemotherapy.  ChlVPP:  Chlorambucil, CLB, 
NSC-3088; Vinblastine, VBL, NSC-49842; Procarbazine, PCB, NSC-77213; 
Prednisone, PRED, NSC-10023.
Arm I:  4-Drug Combination Chemotherapy.  ChlVPP.
Arm II:  Radiotherapy followed by 4-Drug Combination Chemotherapy.  
Irradiation of involved lymph nodes using megavoltage equipment; followed by 
ChlVPP.
Regimen B:  4-Drug Combination Chemotherapy.  ABVD:  Doxorubicin, Adriamycin, 
ADR, NSC-123127; Bleomycin, BLEO, NSC-125066; VBL; Dacarbazine, DTIC, 
NSC-45388.
Arm III:  4-Drug Combination Chemotherapy.  ABVD.
Arm IV:  Radiotherapy followed by 4-Drug Combination Chemotherapy.  
Irradiation of involved lymph nodes using megavoltage equipment; followed by 
ABVD.
Regimen C:  4-Drug Combination Chemotherapy.  OPEC:  Oncovin, Vincristine, 
VCR, NSC-67574; PRED; Etoposide, VP-16, NSC-141540; CLB.

Trial Contact Information

Trial Lead Organizations

University of Cape Town School of Medicine

Nicolas Novitzky, MD, PhD, Protocol chair		Ph: 27-21-404-3073 Email: novitzky@cormack.uct.ac.za