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NCT Number: NCT04755023

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

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.

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Key information

Conditions

Oligodendroglioma; Oligoastrocytoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Oligodendroglioma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide

Drug

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: TEMOBIC

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Feb 15, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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