Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease
NCT ID: NCT00002987
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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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
1997-01-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkin's disease.
Detailed Description
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OUTLINE: This is a randomized multicenter study. Patients are randomized to receive either vincristine/doxorubicin/prednisolone/etoposide/cyclophosphamide/ bleomycin (VAPEC-B) chemotherapy and involved field radiotherapy or mantle radiotherapy only. Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6, doxorubicin IV along with cyclophosphamide IV on week 1, doxorubicin IV and etoposide orally for 5 days on week 3, and vincristine and bleomycin IV on weeks 2 and 4. Involved field radiotherapy is commenced at week 6, within 14 to 21 days of the last chemotherapy treatment. Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks. Patients are followed every 3 months for the first two years, every 4 months for the third year, every 6 months for the fourth and fifth years and annually thereafter.
PROJECTED ACCRUAL: 400 patients will be accrued over 4-5 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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bleomycin sulfate
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisolone
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: No prior treatment
16 Years
75 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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Michael Williams, MD
Role: STUDY_CHAIR
Cambridge University Hospitals NHS Foundation Trust
Locations
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Groote Schuur Hospital, Cape Town
Cape Town, , South Africa
University Birmingham
Birmingham, England, United Kingdom
Bristol Royal Hospital for Sick Children
Bristol, England, United Kingdom
Bristol Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
University Hospitals of Leicester
Leicester, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk & Norwich Hospital
Norwich, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Southend General Hospital
Westcliff-on-Sea, England, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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Radford JA, Williams MV, Hancock BW, et al.: Minimal initial chemotherapy plus involved field radiotherapy (RT) vs. mantle field RT for clinical stage IA/IIA supra-diaphragmatic Hodgkin's disease (HD). Results of the UK Lymphoma Group LY07 trial. [Abstract] Eur J Haematol 73 (Suppl 65): A-E08, 39, 2004.
Other Identifiers
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MRC-UKLG-LY07
Identifier Type: -
Identifier Source: secondary_id
EU-97004
Identifier Type: -
Identifier Source: secondary_id
CDR0000065522
Identifier Type: -
Identifier Source: org_study_id