Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients

Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)

Purpose of the study :

To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.

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