Clinical trial · Interventional
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)
NCT00863460CI-TRIAL-00036948PRECISunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose of the study : To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cranial radiotherapy | Radiation | — | UNRESOLVED |
| intensive chemotherapy and hematopoietic stem cell rescue | Drug | — | UNRESOLVED |
| MTX based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- MTX-based chemotherapy followed by WBRT
- interventionNames
- Radiation: cranial radiotherapy
- Drug: MTX based chemotherapy
- type
- EXPERIMENTAL
- label
- B
- description
- MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
- interventionNames
- Drug: intensive chemotherapy and hematopoietic stem cell rescue
- Drug: MTX based chemotherapy
Primary outcomes (1)
- measure
- 2-years progression-free survival in each arm
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHouillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14. PMID 35834762
- DERIVEDHouillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20. PMID 30785830