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Sponsors and Collaborators: |
University Hospital Carl Gustav Carus Dresden University of Technology |
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Information provided by: | University Hospital Carl Gustav Carus |
ClinicalTrials.gov Identifier: | NCT00188149 |
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.
Condition | Intervention | Phase |
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Hodgkin Disease |
Drug: Combined chemotherapy (ABVD, BACOPP-D) Procedure: Radiation therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 300 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (HL1):
Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
Inclusion criteria (HL2):
Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
Patients in stage
Inclusion criteria (HL3):
Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
Patients in stage
Exclusion Criteria (HL1, HL2 and HL3):
Contact: Ralph Naumann, MD | 458-3855 ext +49 351 | Ralph.Naumann@uniklinikum-dresden.de |
Germany, Sachsen | |
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus | Recruiting |
Dresden, Sachsen, Germany, 01307 | |
Contact: Ralph Naumann, MD |
Principal Investigator: | Ralph Naumann, MD | University Clinic "Carl Gustav Carus" Dresden |
Study ID Numbers: | CGC05MK1002 |
Study First Received: | September 10, 2005 |
Last Updated: | December 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00188149 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Hodgkin's Lymphoma Chemotherapy Radiation therapy PET |
Lymphatic Diseases Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult |
Lymphoproliferative Disorders Hodgkin Disease Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |