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

May 4, 2026 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Assistance Publique - Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven oligodendroglioma or anaplastic oligoastrocytoma, newly diagnosed, resulting or not from a low grade glioma
  • Tumor with measurable contrast enhancement (at least 15 mm in diameter)
  • Surgical procedure limited to a biopsy or partial excision
  • In the event of partial excision, an early postoperative check-up (<72 hours) performed at best by MRI, if not by CT, is required.
  • Time between surgery and inclusion less than or equal to one and a half months (45 days)
  • Age> 18 years old; <70
  • Karnofsky index> 60
  • Stable or reduced dose of corticosteroids in the 15 days prior to inclusion
  • Polynuclear neutrophils> 1500; platelets> 100,000
  • Bilirubin <1.25 x UNL; SGOT, SGPT, PAL <2.5 x UNL
  • Absence of serious uncontrolled pathology
  • Patient having received and understood the information and having signed the consent

Exclusion Criteria:

  • Presence of GBM foci within the tumor
  • Absence of evaluable residue after surgery
  • Previous chemotherapy or radiotherapy
  • Unsatisfactory expected monitoring conditions
  • Pregnant or breastfeeding woman; lack of effective contraception if of childbearing age
  • History of malignant disease (with the exception of CIS of the cervix and basal cell cancer)
  • Contraindications related to the examination of the I.R.M.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Administration of 6 cycles of chemotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Time Frame: At the end of Cycle 2 (each cycle is 28 days)
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
At the end of Cycle 2 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Time Frame: At the end of Cycle 4 (each cycle is 28 days)
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
At the end of Cycle 4 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
At the end of Cycle 6 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Time Frame: 1 month after radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
1 month after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2005

Primary Completion (Actual)

March 15, 2009

Study Completion (Actual)

December 15, 2010

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oligodendroglioma; Oligoastrocytoma

Clinical Trials on Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe