Clinical trial · Interventional
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
NCT00503594CI-TRIAL-00007586CNSLymphomaunknownPhase 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)
The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) : * Methotrexate, procarbazine, vincristine and cytarabine * Methotrexate and temozolomide
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate and temozolomide | Drug | — | UNRESOLVED |
| Methotrexate , procarbazine ,vincristine ,cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine.
- interventionNames
- Drug: Methotrexate and temozolomide
- type
- ACTIVE_COMPARATOR
- label
- bras conventional
- description
- bras conventional
- interventionNames
- Drug: Methotrexate , procarbazine ,vincristine ,cytarabine
Primary outcomes (1)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy * KPS 40 or higher * Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan * Leucocytes\>3.500/mm3, platelets\>130.000/mm3, Bilirubin \< 2 mg, transaminases \< 2.5 N), creatinine \< 150 μM/l, creatinine clearance \> 40 ml/min * Age ≥ 60 years * Negative HIV test * Signature of informed consent Exclusion Criteria: * previous cranial radiotherapy * prior chemotherapy for primary central nervous system lymphoma * presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ ) * systemic lymphoma (outside the CNS) * Isolated ocular lymphoma * Immunosuppressed patients (HIV , use of immunosuppressors) * Other uncontrolled or progressive disease compromising shot-term survival * Severe renal or hepatic disease * Patients not legally covered by the French Social Security * Inability to swallow the medication
References
Publications (2)
- RESULTOmuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. doi: 10.3171/foc.2006.21.5.13. PMID 17134114
- DERIVEDOmuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrie M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3. PMID 26688235