RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
OBJECTIVES: Primary * Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma. * Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis. OUTLINE: This is an open-label, multicenter study. * Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease. * Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy. Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
Disease-free survival by routine imaging
Time frame: 6 month intervals
Overall survival by routine imaging
Time frame: 5 years
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Treatment
Treatment
Treatment
Treatment
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany
Wansbeck General Hospital
Ashington, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bradford Royal Infirmary
Bradford, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
...and 44 more locations