ASCT-RT
Potential Benefit of Radiotherapy for Patients Undergoing Autologous Stem Cell Transplantation for Relapsed or Refractory Hodgkin's Lymphoma
Objectives, structure and design of the Study
Study design
This will be a retrospective observational study for patients treated with ASCT, comparing those who received peritransplant RT with a subgroup who received a chemotherapy-alone regimen for a relapsed/refractory HL between 2004 and 2014.
Aim of this retrospective study is to investigate for a possible role for RT by comparing patients who received RT (prior or after ASCT) and patients who received salvage chemotherapy (CT) alone.
Primary objective
Overall survival (OS) at 3 and 5 years.
Secondary objectives
- Progression free survival (PFS) at 3 and 5 years
- Comparison of late effects between the two cohorts of treatment
Sample size
400 Patients
Number of Centers and location of the Study
20 Centers in Italy
1 Extra-ue center
Study duration
4 years based on the following assumptions:
- Recruitment: 12 months
- Follow-up: 36 months
Study start date
January 2017