Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Official Title: Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma
Study ID: NCT00005867
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: * Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP). * Compare the early and late toxicities of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment. * Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England, United Kingdom
Horton Hospital, Banbury, England, United Kingdom
Basildon University Hospital, Basildon, England, United Kingdom
Birmingham Heartlands Hospital, Birmingham, England, United Kingdom
Bradford Hospitals NHS Trust, Bradford, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom
Cheltenham General Hospital, Cheltenham, England, United Kingdom
Countess of Chester Hospital NHS Foundation Trust, Chester, England, United Kingdom
Saint Richards Hospital, Chichester, England, United Kingdom
Essex County Hospital, Colchester, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
Russells Hall Hospital, Dudley, England, United Kingdom
Chase Farm Hospital, Enfield, England, United Kingdom
Medway Maritime Hospital, Gillingham Kent, England, United Kingdom
Hull Royal Infirmary, Hull, England, United Kingdom
Hinchingbrooke Hospital, Huntingdon, England, United Kingdom
Queen Elizabeth Hospital, King's Lynn, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, England, United Kingdom
Aintree University Hospital, Liverpool, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
St. Thomas' Hospital, London, England, United Kingdom
St. George's Hospital, London, England, United Kingdom
Middlesex Hospital, London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
Norfolk and Norwich University Hospital, Norwich, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
Pontefract General Infirmary, Pontefract West Yorkshire, England, United Kingdom
Oldchurch Hospital, Romford, England, United Kingdom
Scunthorpe General Hospital, Scunthorpe, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Southampton University Hospital NHS Trust, Southampton, England, United Kingdom
University Hospital of North Staffordshire, Stoke-On-Trent Staffs, England, United Kingdom
East Surrey Hospital, Surrey, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom
Sandwell General Hospital, West Bromwich, England, United Kingdom
Cancer Care Centre at York Hospital, York, England, United Kingdom
Centre for Cancer Research and Cell Biology at Belfast City Hospital, Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Pinderfields Hospital NHS Trust, Wakefield, Scotland, United Kingdom
Ysbyty Gwynedd, Bangor, Wales, United Kingdom
University Hospital of Wales, Cardiff, Wales, United Kingdom
Glan Clywd District General Hospital, Rhyl, Denbighshire, Wales, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital, Rhyl, Denbighshire, Wales, United Kingdom
Contact Details
Name: Ruth Pettengell, MD
Affiliation: St. George's Hospital
Role: STUDY_CHAIR
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