drugset / Trial / NCT04755023

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

NCT04755023

Phase 2 Completed 53 enrolled Assistance Publique Hopitaux De Marseille
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-12-21
Primary completion
2009-03-15
Completion
2010-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 110 mg/m2
Subject carmustine Small molecule 150 mg/m2