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A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease

Phase 3
Open (Enrolling)

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Trial Information

A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease

OBJECTIVES: I. Determine whether a four-drug anthracycline-based regimen or a seven-drug
hybrid or eight-drug alternating regimen is the optimal treatment for patients with advanced
Hodgkin's disease.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, and dacarbazine
IV on days 1 and 15. Courses repeat every 4 weeks. Arm II (ChlVPP/PABLOE): Patients receive
oral chlorambucil, procarbazine, and prednisolone on days 1-14; vinblastine IV on days 1 and
8; doxorubicin IV on day 29; vincristine IV and bleomycin IV on days 29 and 36; oral
etoposide on days 29-31; and oral prednisolone again on days 29-38. Courses repeat every 7
weeks. OR (Hybrid - ChlVPP/EVA): Patients receive vincristine IV on day 1; oral etoposide on
days 1-5; oral chlorambucil, procarbazine, and prednisolone on days 1-7; and doxorubicin IV
and vinblastine IV on day 8. Courses repeat every 4 weeks. Patients in both arms receive up
to 6-8 courses of treatment. Radiotherapy may be given to sites of previous bulk disease for
patients in complete remission or uncertain remission. Patients who achieve partial
remission may receive radiotherapy to residual disease sites. Patients who fail to respond,
or have disease progression, may receive induction therapy followed by high-dose
consolidation therapy. Patients are followed every 3 months for 2 years, every 6 months for
5 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced Hodgkin's disease requiring
systemic therapy Stage IA or IIA disease with bulky disease or more than three sites of
involvement are also eligible

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified
Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other
active malignancy within 5 years HIV negative Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for Hodgkin's disease Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy for Hodgkin's disease Surgery: Not specified

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Barry W. Hancock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Research Centre at Weston Park Hospital


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma