Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease
- Conditions
- Lymphoma
- Registration Number
- NCT00002987
- Lead Sponsor
- Medical Research Council
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
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
OBJECTIVES: I. Determine the recurrence rate and long term survival of patients with early stage Hodgkin's disease given vincristine/doxorubicin/prednisolone/ etoposide/cyclophosphamide/bleomycin (VAPEC-B) chemotherapy and involved field radiation vs mantle radiotherapy.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Groote Schuur Hospital, Cape Town
🇿🇦Cape Town, South Africa
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Bristol Royal Hospital for Sick Children
🇬🇧Bristol, England, United Kingdom
University Birmingham
🇬🇧Birmingham, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
University Hospitals of Leicester
🇬🇧Leicester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Royal Hospital for Sick Children
🇬🇧Edinburgh, Scotland, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Norfolk & Norwich Hospital
🇬🇧Norwich, England, United Kingdom
Southend General Hospital
🇬🇧Westcliff-On-Sea, England, United Kingdom
Bristol Oncology Centre
🇬🇧Bristol, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom