Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease

December 3, 2013 updated by: Medical Research Council

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Weston Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Study Chair: Barry W. Hancock, MD, Cancer Research Centre at Weston Park Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 11, 2004

First Posted (Estimate)

March 12, 2004

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066441
  • MRC-UKLG-LY09
  • EU-98020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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