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| Name | Class |
|---|---|
| French Innovative Leukemia Organisation | OTHER |
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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) :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| bras conventional | Active Comparator | bras conventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate and temozolomide | Drug | Methotrexate and temozolomide |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | at one year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival:median and overall survival | at one and two years | |
| Response rates | at end of treatment | |
| Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio OMURO, MD,PhD | Contact | + 33(0) 1 42 16 41 60 | antonio.omuro@psl.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antonio OMURO, MD, | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe hospitalier la Pitié Salpétrière | Recruiting | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17134114 | Result | 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. | |
| 26688235 | Derived | 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. |
| Label | URL |
|---|---|
| A review on chemotherapy options for primary central nervous system lymphoma | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate , procarbazine ,vincristine ,cytarabine |
| Drug |
Methotrexate , procarbazine ,vincristine ,cytarabine |
|
| during treatment |
| Late toxicity | 2 to 5 years after treatment |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |