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COMPLETED
NCT04755023
PHASE2

Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

Summary

The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC. If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC. In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2005-12-21

Completion Date

2010-12-15

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

DRUG

Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide

Chemotherapy (BCNU) will be delivered at Day 1. between day 1 and day 5, temolozomide will be administered . One cycle is planned every 6 weeks until 6 cycles.

Locations (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, France