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Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose methotrexate alone | Active Comparator |
| |
| High-dose methotrexate associated with high dose cytarabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dose methotrexate | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| The main endpoint is the complete remission (CR) rate after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | ||
| Response duration (time to relapse or progression) for responder patients | ||
| Overall survival |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres JM Ferreri, MD | Radiochemotherapy. San Raffaele Hospital. Milan | Study Chair |
| Michele Reni, MD | Radiochemotherapy. San Raffaele Hospital. Milan | Study Chair |
| Emanuele Zucca, MD | International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland (IOSI) | Bellinzona | 6500 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19767089 | Derived | Ferreri AJ, Reni M, Foppoli M, Martelli M, Pangalis GA, Frezzato M, Cabras MG, Fabbri A, Corazzelli G, Ilariucci F, Rossi G, Soffietti R, Stelitano C, Vallisa D, Zaja F, Zoppegno L, Aondio GM, Avvisati G, Balzarotti M, Brandes AA, Fajardo J, Gomez H, Guarini A, Pinotti G, Rigacci L, Uhlmann C, Picozzi P, Vezzulli P, Ponzoni M, Zucca E, Caligaris-Cappio F, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). High-dose cytarabine plus high-dose methotrexate versus high-dose methotrexate alone in patients with primary CNS lymphoma: a randomised phase 2 trial. Lancet. 2009 Oct 31;374(9700):1512-20. doi: 10.1016/S0140-6736(09)61416-1. Epub 2009 Sep 18. |
| Label | URL |
|---|---|
| Click here for more information about this study | View source |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D003561 | Cytarabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| high dose cytarabine |
| Drug |
|
| radiotherapy | Radiation |
|
| Event-free survival |
| Meningeal relapse rate |
| Early and late neurotoxicity |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |