Clinical Trial: Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Pri
Brief Summary:
Purpose of the study :
To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
Detailed Summary:
Sponsor: Institut Curie
Current Primary Outcome: 2-years progression-free survival in each arm [ Time Frame: 2 years after inclusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall response rate at the end of the procedure [ Time Frame: at the end of procedure at 1 and 2 years ]
- Overall survival [ Time Frame: 2 years after inclusion ]
- Event-free survival [ Time Frame: 2 years after inclusion ]
- Neurotoxicity [ Time Frame: each years during ten years ]
Original Secondary Outcome: Same as current
Information By: Institut Curie
Dates:
Date Received: March 16, 2009
Date Started: October 2008
Date Completion: February 2025
Last Updated: January 23, 2017
Last Verified: January 2017
