RANDOMIZED PHASE II ASSAY OF CHEMOTHERAPY WITH METOTREXATE IN HIGH DOSES ONLY OR ASSOCIATED WITH CITARABINE IN HIGH DOSE, FOLLOWED BY RADIOTHERAPY ADEQUATE TO AGE AND RESPONSE FOR IMMUNOCOMPROMISED PATIENTS WITH RECENT DIAGNOSIS OF PRIMARY LYMPHOMA OF THE CENTRAL NERVOUS SYSTEM
Not Applicable
- Conditions
- -C819 Hodgkin lymphoma, unspecifiedHodgkin lymphoma, unspecifiedC819
- Registration Number
- PER-082-03
- Lead Sponsor
- INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Histological or cytological diagnosis of non-Hodgkins liymphoma.
Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
Disease exciusively localized into the central nervous system, cranial nerves or eyes.
Untreated patients (patients treated with steroids alone are eligibie).
At least one measurable lesion.
Age 18-75 years.
ECOG performance status < 3
Exclusion Criteria
Not contemplated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:• Complete response (CR): disappearance of the evidence of Lymphoma without the use of corticosteroids in the last two weeks.<br>• Partial response (PR):> 50% decrease in tumor size, with stable or reduced doses of corticosteroids.<br>• Disease progression (PE):> 25% increases the size of the tumor or a new lesion.<br>• Disease Stabilization (SE): No variations.<br>Measure:Association of Cytarabine and Methotrexate is more effective than treatment with Methotrexate as a single agent, in terms of frequency and duration of remission.<br>Timepoints:each week<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:not contemplated<br>Measure:not contemplated<br>Timepoints:not contemplated<br>