Trial Information
HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
Inclusion Criteria:
- Hodgkin Lymphoma
- CS I, II without risk factors
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Andreas Engert, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cologne
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
HD16
NCT ID:
NCT00736320
Start Date:
November 2009
Completion Date:
Related Keywords:
- Hodgkin Lymphoma
- Hodgkin Lymphoma
- early stage
- PET
- Hodgkin Disease
- Lymphoma