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CompletedNCT04755023TEMOBICUpdated May 7, 2026

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

A Phase 2 interventional study of Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide in Oligodendroglioma; Oligoastrocytoma, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Assistance Publique Hopitaux De Marseille · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 15 years 1 month after the study started (first participant enrolled Dec 2005, registered Feb 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Oligodendroglioma; Oligoastrocytoma

Keywords

  • chemotherapy
  • BCNU-Temozolomide
  • radiotherapy
03

In context

Oligodendroglioma

218 studies on the registry are indexed under Oligodendroglioma; 31 are open to participants now.

This study's enrollment of 53 is above the median of 32 across 180 interventional studies indexed under Oligodendroglioma.

Browse Oligodendroglioma studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Treatment Arm

    Administration of 6 cycles of chemotherapy

    Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide

Interventions

  • DrugBis-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.

06

What researchers measure

Primary outcomes

  1. Objective response rate of the BCNU-TMZ combination administered before radiotherapy

    In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment

    Time frame: At the end of Cycle 2 (each cycle is 28 days)

  2. Objective response rate of the BCNU-TMZ combination administered before radiotherapy

    In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment

    Time frame: At the end of Cycle 4 (each cycle is 28 days)

  3. Objective response rate of the BCNU-TMZ combination administered before radiotherapy

    In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment

    Time frame: At the end of Cycle 6 (each cycle is 28 days)

  4. Objective response rate of the BCNU-TMZ combination administered before radiotherapy

    In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment

    Time frame: 1 month after radiotherapy

07

Study locations

1 site
  • Assistance Publique - Hôpitaux de Marseille
    Marseille, 13005, France
08

References and documents

Publications

  • Tabouret E, Fabbro M, Autran D, Hoang-Xuan K, Taillandier L, Ducray F, Barrie M, Sanson M, Kerr C, Cartalat-Carel S, Loundou A, Guillevin R, Mokhtari K, Figarella-Branger D, Delattre JY, Chinot O. TEMOBIC: Phase II Trial of Neoadjuvant Chemotherapy for Unresectable Anaplastic Gliomas: An ANOCEF Study. Oncologist. 2021 Aug;26(8):647-e1304. doi: 10.1002/onco.13765. Epub 2021 Apr 20. PubMed 33783067 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04755023
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Feb 15, 2021
Start date
Dec 21, 2005
Primary completion
Mar 15, 2009
Completion
Dec 15, 2010
Last update
May 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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