Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188149
Status:
UNKNOWN
Last Update Posted:
2005-12-29
First Post:
2005-09-10
Brief Title:
Optimization of the Primary Therapy for Patients With Hodgkins Disease and Evaluation of PET
Sponsor:
University Hospital Carl Gustav Carus
Organization:
University Hospital Carl Gustav Carus
Study Overview
Official Title:
Optimization of the Primary Therapy for Patients With Hodgkins 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
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prognosis of patients with Hodgkins 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 15 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 15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None