Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease
NCT ID: NCT00003421
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
1998-06-30
2005-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
ABVD regimen
chlorambucil
dacarbazine
doxorubicin hydrochloride
etoposide
prednisolone
procarbazine hydrochloride
vinblastine sulfate
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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Barry W. Hancock, MD
Role: STUDY_CHAIR
Cancer Research Centre at Weston Park Hospital
Locations
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St. James's Hospital
Leeds, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Countries
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References
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Johnson PW, Radford JA, Cullen MH, Sydes MR, Walewski J, Jack AS, MacLennan KA, Stenning SP, Clawson S, Smith P, Ryder D, Hancock BW; United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519). Comparison of ABVD and alternating or hybrid multidrug regimens for the treatment of advanced Hodgkin's lymphoma: results of the United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519). J Clin Oncol. 2005 Dec 20;23(36):9208-18. doi: 10.1200/JCO.2005.03.2151. Epub 2005 Nov 28.
Other Identifiers
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MRC-UKLG-LY09
Identifier Type: -
Identifier Source: secondary_id
EU-98020
Identifier Type: -
Identifier Source: secondary_id
CDR0000066441
Identifier Type: -
Identifier Source: org_study_id