Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Phase 2
Active, not recruiting
- Conditions
- Primary Central Nervous System Lymphoma
- Interventions
- Radiation: cranial radiotherapyDrug: intensive chemotherapy and hematopoietic stem cell rescue
- Registration Number
- NCT00863460
- Lead Sponsor
- Institut Curie
- 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 Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
- All histological types of non-Hodgkin's lymphoma, except MALT
- Age > 18 and < 60 ans.
- Negative for HIV, HCV and HBV
- Written informed consent -
Exclusion Criteria
- Age < 18 or > 60 ans
- Isolated intra-ocular lymphoma
- Previous history of indolent lymphoma
- Previous chemotherapy or radiotherapy for PCNSL
- Isolated CNS relapse of systemic NHL
- Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
- Renal insufficiency or creatinin clearance < 60 ml/min
- Liver enzymes > 3N.
- Platelets < 100 000/mm3 or neutrophils < 1500/mm3)
- Previous history of organ transplantation or other cause of severe immunodeficiency
- Pregnancy or active sexual women with no contraception
- Unable to follow the protocol for any reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A cranial radiotherapy MTX-based chemotherapy followed by WBRT A MTX based chemotherapy MTX-based chemotherapy followed by WBRT B intensive chemotherapy and hematopoietic stem cell rescue MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue B MTX based chemotherapy MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
- Primary Outcome Measures
Name Time Method 2-years progression-free survival in each arm 2 years after inclusion
- Secondary Outcome Measures
Name Time Method Overall survival 2 years after inclusion Overall response rate at the end of the procedure at the end of procedure at 1 and 2 years Event-free survival 2 years after inclusion Neurotoxicity each years during ten years
Trial Locations
- Locations (23)
Cancérologie Hôpital Sud
🇫🇷Amiens, France
Chu D'Angers
🇫🇷Angers, France
CHR Argenteuil
🇫🇷Argenteuil, France
CHU de Besancon
🇫🇷Besançon, France
Institut Bergonié
🇫🇷Bordeaux, France
CHU Hôtel Dieu
🇫🇷Clermont-Ferrand, France
CHU Michalon
🇫🇷Grenoble, France
Centre Hospitalier Lens
🇫🇷Lens, France
CHU de Limoges
🇫🇷Limoges, France
CHU de la Timone
🇫🇷Marseille, France
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