NCT00188149

Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET

Optimization of the Primary Therapy for Patients With Hodgkin's Lymphoma and Evaluation of the Positron Emission Tomography (PET) as a Diagnostic Tool for Primary Staging and Assessment of the Effects of the Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: University Hospital Carl Gustav Carus · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	Combined chemotherapy (ABVD, BACOPP-D)
PROCEDURE	Radiation therapy

Timeline

• Start date: 2000-05-01
• Completion: 2007-12-01
• First posted: 2005-09-16
• Last updated: 2005-12-29

Locations

1 site across 1 country: Germany