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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153530
Other study ID # G-PCNSL-SG1
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated December 23, 2009
Start date May 2000
Est. completion date May 2009

Study information

Verified date July 2009
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The aim of the study is to deliver primary systemic high-dose methotrexate (MTX) treatment to PCNSL patients and to define the role of whole brain irradiation (WBI) in primary therapy, i.e., to analyze whether patients who have undergone primary chemotherapy can postpone irradiation with its possible late sequelae until recurrence without incurring losses in progression-free and overall survival. This is studied here for the first time worldwide in a systematic, controlled and randomized manner. In this study, one arm with six cycles of high-dose MTX and subsequent irradiation (A1), which comes closest to a "standard arm of primary therapy", at least according to the majority assessment, is compared to irradiation at recurrence with regard to time to progression and overall survival (A2). In primary therapy failure, it will also be analyzed to what extent salvage therapy with AraC is equivalent to irradiation as the "standard arm" with regard to time to progression and overall survival (arm B1 and B2).


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
methotrexate
chemotherapy with radiotherapy chemotherapy without radiotherapy
Radiation:
radiotherapy
whole-brain irradiation

Locations

Country Name City State
Germany Charite Campus Benjamin Franklin Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival 3 years
Secondary progression-free survival 3 years
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