HD17 for Intermediate Stage Hodgkin Lymphoma
Phase 3
Completed
- Conditions
- Hodgkin Lymphoma
- Interventions
- Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)
- Registration Number
- NCT01356680
- Lead Sponsor
- University of Cologne
- Brief Summary
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
Inclusion Criteria
- Hodgkin Lymphoma
- CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
- large mediastinal mass (>1/3 of maximum transverse thorax diameter)
- extranodal involvement
- elevated ESR
- 3 or more involved nodal areas
- written informed consent
Exclusion Criteria
- Leucocytes <3000/µl
- Platelets < 100000/µl
- Hodgkin Lymphoma as composite lymphoma
- Activity Index (WHO) >2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy Arm A 30Gy IF-RT (Involved-Field Radiotherapy) 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy Arm B BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy Arm B 30Gy IN-RT (Involved-Node Radiotherapy) 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy Arm A ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy Arm B ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
- Primary Outcome Measures
Name Time Method Progression Free Survival 3 years
- Secondary Outcome Measures
Name Time Method Overall Survival 3 years CR rate 6 months Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
Trial Locations
- Locations (1)
1st Dept. of Medicine, Cologne University Hospital
🇩🇪Cologne, Germany