Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
NCT ID: NCT00503594
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
92 participants
INTERVENTIONAL
2007-07-31
2012-07-31
Brief Summary
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* Methotrexate, procarbazine, vincristine and cytarabine
* Methotrexate and temozolomide
Detailed Description
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Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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.
Methotrexate and temozolomide
Methotrexate and temozolomide
bras conventional
bras conventional
Methotrexate , procarbazine ,vincristine ,cytarabine
Methotrexate , procarbazine ,vincristine ,cytarabine
Interventions
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Methotrexate and temozolomide
Methotrexate and temozolomide
Methotrexate , procarbazine ,vincristine ,cytarabine
Methotrexate , procarbazine ,vincristine ,cytarabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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French Innovative Leukemia Organisation
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Antonio OMURO, MD,
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Groupe hospitalier la Pitié Salpétrière
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Antonio OMURO, MD,PhD
Role: primary
References
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Omuro 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.
Omuro 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.
Related Links
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A review on chemotherapy options for primary central nervous system lymphoma
Other Identifiers
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P060239
Identifier Type: -
Identifier Source: org_study_id