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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00863460

Acronym

PRECIS

Enrollment

140

Registered

2009-03-18

Start date

2008-10-03

Completion date

2026-05-31

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Central Nervous System Lymphoma

Brief summary

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

Interventions

RADIATIONcranial radiotherapy

40 Gy

DRUGintensive chemotherapy and hematopoietic stem cell rescue

intensive chemotherapy and hematopoietic stem cell rescue

DRUGMTX based chemotherapy

R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
2-years progression-free survival in each arm	2 years after inclusion

Secondary

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026