Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine (CNSLymphoma)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00503594|
Recruitment Status : Unknown
Verified July 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : July 19, 2007
Last Update Posted : July 30, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Methotrexate and temozolomide Drug: Methotrexate , procarbazine ,vincristine ,cytarabine||Phase 2|
The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly|
|Study Start Date :||July 2007|
|Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||July 2012|
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.
Drug: Methotrexate and temozolomide
Methotrexate and temozolomide
Active Comparator: bras conventional
Drug: Methotrexate , procarbazine ,vincristine ,cytarabine
Methotrexate , procarbazine ,vincristine ,cytarabine
- Progression-free survival [ Time Frame: at one year ]
- Overall survival:median and overall survival [ Time Frame: at one and two years ]
- Response rates [ Time Frame: at end of treatment ]
- Toxicity [ Time Frame: during treatment ]
- Late toxicity [ Time Frame: 2 to 5 years after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503594
|Contact: Antonio OMURO, MD,PhD||+ 33(0) 1 42 16 41 email@example.com|
|Groupe hospitalier la Pitié Salpétrière||Recruiting|
|Paris, France, 75013|
|Contact: Antonio OMURO, MD,PhD + 33(0) 1 42 16 41 60 firstname.lastname@example.org|
|Principal Investigator:||Antonio OMURO, MD,||Assistance Publique - Hôpitaux de Paris|