Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00041210
- Lead Sponsor
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
* Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.
All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 850
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method Overall survival Toxicity
Trial Locations
- Locations (37)
Pinderfields General Hospital
🇬🇧Wakefield, Scotland, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
City Hospital - Birmingham
🇬🇧West Bromwich, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Monklands General Hospital
🇬🇧Airdrie, Scotland, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
King George Hospital
🇬🇧Ilford, Essex, England, United Kingdom
James Paget Hospital
🇬🇧Norfolk, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Hemel Hempstead General
🇬🇧Hemel Hempstead, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
University College Hospital - London
🇬🇧London, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Craigavon Area Hospital
🇬🇧Craigavon, Northern Ireland, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom