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Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)

NCT00153530 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2009-12-24

No results posted yet for this study

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).

Conditions

  • Central Nervous System Lymphoma

Interventions

DRUG

methotrexate

1. chemotherapy with radiotherapy 2. chemotherapy without radiotherapy

RADIATION

radiotherapy

whole-brain irradiation

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Eckhard Thiel, MD · Charite Campus Benjamin Franklin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-05-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153530 on ClinicalTrials.gov