Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET
- Conditions
- Hodgkin Disease
- Registration Number
- NCT00188149
- Lead Sponsor
- University Hospital Carl Gustav Carus
- Brief Summary
Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the last decade. Therefore, the impact of treatment associated long-term toxicities and late effects such as second cancers increased. The purpose of this prospective multicenter trial is to show the feasibility of the treatment with ABVD alone in patients with limited stage (HL1) and intermediate stage (HL2) disease and of an intensified etoposide-free chemotherapy regimen for patients with advanced disease (HL3) including 18F-FDG-PET evaluation.
- Detailed Description
The aim in limited and intermediate stages is to reduce the toxicity by omitting the subsequent radiotherapy in patients with complete remission after ABVD chemotherapy. Patients with limited disease receive four cycles, patients with intermediate disease (according to the criteria of the German Hodgkin Study group, GHSG) receice six cycles of ABVD. In case of residual mass (\> 1.5 cm), additional involved field irradiation is planned. The aim in advanced disease using BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine, is to reduce the hematological toxicity and the secondary leukemias by omitting etoposide (in comparison to the BEACOPP escalated regimen). All patients receive eight cycles of the BACOPP-D regimen. In case of residual mass (\> 1.5 cm), additional involved field irradiation is planned. Additionally, we want to evaluate the CT- and PET-based remission status after chemotherapy and at final staging.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method - Feasibility and acute toxicity of the therapy - The Free from Therapy Failure (FFTF) rate after one year - Event-Free Survival (EFS) rate and overall survival rate - Evaluation of the PET as a diagnostic tool for the primary tumor staging as well for assessment of the effects of the therapy
- Secondary Outcome Measures
Name Time Method - Evaluation of the quality of life of the patients during and after the therapy - Occurence of late toxicity after the end of the therapy
Trial Locations
- Locations (1)
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
🇩🇪Dresden, Sachsen, Germany