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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 15 to 69 CRC-TU-HO3001 EU-93029

Objectives

I.  Compare the complete remission rate and relapse-free survival produced by 
ChlVPP (chlorambucil/vinblastine/prednisolone/procarbazine) alternating with 
PABlOE (prednisolone/doxorubicin/bleomycin/vincristine/etoposide) vs. PABlOE 
alone in patients with Hodgkin's disease for whom chemotherapy is indicated.

II.  Document the toxicity of each regimen, with particular regard to 
frequency of second malignancy, infertility, and pulmonary and cardiac 
toxicity.

III.  Assess the role of radiotherapy following chemotherapy-induced CR in 
selected cases.

IV.  Assess the quality of life of patients treated on each regimen.

Entry Criteria

Disease Characteristics:

Biopsy-proven Hodgkin's disease for which chemotherapy is indicated, i.e., Ann
Arbor Stages I and IIA (poor prognosis), IB, IIB, III, and IV

Prior/Concurrent Therapy:

No prior therapy

Patient Characteristics:

Age:
  15 to 69

Performance status:
  Not specified

Life expectancy:
  No irreversible medical condition severely limiting life expectancy

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No irreversible medical condition that would preclude combination
     chemotherapy
  Adequate long-term follow-up possible

Expected Enrollment

350 patients will be treated on each arm.

Outline

Randomized study.  All patients are randomized to Arms I and II; those with 
bulky nodal disease (i.e., greater than 5 cm) who achieve CR (or equivocal CR, 
i.e., minimal residual mass on CT or MRI that could be disease or fibrosis) 
are randomized to Arms III and IV.

The following acronyms are used:
  BLEO   Bleomycin, NSC-125066
  CLB    Chlorambucil, NSC-3088
  DOX    Doxorubicin, NSC-123127
  PCB    Procarbazine, NSC-77213
  PRDL   Prednisolone, NSC-9900
  VBL    Vinblastine, NSC-49842
  VCR    Vincristine, NSC-67574
  VP-16  Etoposide, NSC-141540

Arm I:  5-Drug Combination Chemotherapy.  PABlOE:  PRDL; DOX; BLEO; VCR; VP-16.

Arm II:  4-Drug Combination Chemotherapy alternating with 5-Drug Combination 
Chemotherapy.  ChlVPP:  CLB; VBL; PCB; PRDL; alternating with PABlOE.

Arm III:  Adjuvant Radiotherapy.  Equipment not specified.

Arm IV:  No further therapy.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit - Birmingham

Michael H. Cullen, MD, Protocol chair		Ph: 0121-627-2444