HD10 for Early Stages
Phase 3
Completed
- Conditions
- Hodgkin´s Lymphoma
- Interventions
- Radiation: 20 Gy IF-RTRadiation: 30 Gy IF-RT
- Registration Number
- NCT00265018
- Lead Sponsor
- University of Cologne
- Brief Summary
This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1370
Inclusion Criteria
-
Hodgkin´s lymphoma (histologically proven)
-
CS (PS) IA, IB, IIA,IIB without any of the following risk factors:
- 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 Arm A Vinblastine - Arm A Bleomycin - Arm B DTIC - Arm B 20 Gy IF-RT - Arm C Adriamycin - Arm C Vinblastine - Arm C DTIC - Arm C 30 Gy IF-RT - Arm D Adriamycin - Arm D Bleomycin - Arm D Vinblastine - Arm D 20 Gy IF-RT - Arm A Adriamycin - Arm A 30 Gy IF-RT - Arm A DTIC - Arm B Bleomycin - Arm B Adriamycin - Arm B Vinblastine - Arm C Bleomycin - Arm D DTIC -
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) 5 years
- Secondary Outcome Measures
Name Time Method