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

Study Overview
=================
Brief Summary
-----------------
Purpose of the study : To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.

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 Primary Central Nervous System in Young Patients (< 60 y)

Conditions
-----------------
Primary Central Nervous System Lymphoma

Intervention / Treatment
-----------------
* Radiation: cranial radiotherapy
* Drug: intensive chemotherapy and hematopoietic stem cell rescue
* Drug: MTX based chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>MTX-based chemotherapy followed by WBRT | Radiation: cranial radiotherapy<br>* 40 Gy<br>Drug: MTX based chemotherapy<br>* R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80<br>* Other names: Aracytine IV (3g/m²) day1 & day2;|
| Experimental: B<br>MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue | Drug: intensive chemotherapy and hematopoietic stem cell rescue<br>* intensive chemotherapy and hematopoietic stem cell rescue<br>* Other names: Reinjection of hematopoietic stem cells day0;Drug: MTX based chemotherapy<br>* R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80<br>* Other names: Aracytine IV (3g/m²) day1 & day2;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-years progression-free survival in each arm |  | 2 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate at the end of the procedure |  | at the end of procedure at 1 and 2 years | 
| Overall survival |  | 2 years after inclusion | 
| Event-free survival |  | 2 years after inclusion | 
| Neurotoxicity |  | each years during ten years |