HD11 for Intermediate Stages
Phase 3
Completed
- Conditions
- Hodgkin´s Lymphoma
- Interventions
- Registration Number
- NCT00264953
- Lead Sponsor
- University of Cologne
- Brief Summary
This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1395
Inclusion Criteria
-
Hodgkin´s lymphoma (histologically proven)
-
CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d
- bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
- extranodal involvement
- ESR > 50 (A), > 30 (B-symptoms)
- 3 or more lymph node areas involved
-
written informaed consent
Exclusion Criteria
- Leukocytes <3000/microl
- Platelets <100000/microl
- Hodgkin´s Disease as "composite lymphoma"
- Activity index (WHO) < grade 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A Bleomycin 4x ABVD plus 30Gy IF-RT A radiation therapy 4x ABVD plus 30Gy IF-RT A Vinblastine 4x ABVD plus 30Gy IF-RT C radiation therapy 4x BEACOPP baseline plus 30Gy IF-RT B Adriamycin 4x ABVD plus 20Gy IF-RT B Bleomycin 4x ABVD plus 20Gy IF-RT B Vinblastine 4x ABVD plus 20Gy IF-RT B DTIC 4x ABVD plus 20Gy IF-RT B radiation therapy 4x ABVD plus 20Gy IF-RT D radiation therapy 4x BEACOPP baseline plus 20Gy IF-RT A DTIC 4x ABVD plus 30Gy IF-RT A Adriamycin 4x ABVD plus 30Gy IF-RT C Procarbazine 4x BEACOPP baseline plus 30Gy IF-RT C Adriamycin 4x BEACOPP baseline plus 30Gy IF-RT C Bleomycin 4x BEACOPP baseline plus 30Gy IF-RT C Etoposide 4x BEACOPP baseline plus 30Gy IF-RT C Prednisone 4x BEACOPP baseline plus 30Gy IF-RT C Vincristine 4x BEACOPP baseline plus 30Gy IF-RT D Adriamycin 4x BEACOPP baseline plus 20Gy IF-RT D Procarbazine 4x BEACOPP baseline plus 20Gy IF-RT D Bleomycin 4x BEACOPP baseline plus 20Gy IF-RT D Etoposide 4x BEACOPP baseline plus 20Gy IF-RT D Prednisone 4x BEACOPP baseline plus 20Gy IF-RT D Vincristine 4x BEACOPP baseline plus 20Gy IF-RT
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method