Oligodendroglioma; OligoastrocytomaPhase 2TEMOBICNCT04755023
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
A Phase 2 study testing Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide in people with Oligodendroglioma; Oligoastrocytoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oligodendroglioma; Oligoastrocytoma
- What is being tested?
- Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2005to 15 Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Oligodendroglioma; Oligoastrocytoma
- Being tested
- Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide
- Keywords
- chemotherapy, BCNU-Temozolomide, radiotherapy
- Medical subject headings
- Oligodendroglioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Administration of 6 cycles of chemotherapy Receives: Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Measured: At the end of Cycle 2 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Measured: At the end of Cycle 4 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Measured: At the end of Cycle 6 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Measured: 1 month after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start21 Dec 2005
- Primary completion15 Mar 2009
- Study completion15 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligodendroglioma; OligoastrocytomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755023
- Sponsor's protocol ID
- 2004-30
- Acronym
- TEMOBIC
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
- ClinicalTrials.gov ID
- NCT04755023
- Acronym / sponsor ID
- TEMOBIC / 2004-30
- Conditions
- Oligodendroglioma; Oligoastrocytoma
- Keywords
- chemotherapy, BCNU-Temozolomide, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 21 Dec 2005 (actual)
- Primary completion
- 15 Mar 2009 (actual)
- Study completion
- 15 Dec 2010 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomideAdministration of 6 cycles of chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomideChemotherapy (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. | Drug | Treatment Arm |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 33783067Tabouret 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.
- Individual participant dataSharing planned: No
Related trials for Oligodendroglioma; Oligoastrocytoma
Active, not recruitingPhase 1
Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma
Recurrent High-grade Glioma, Grade III Astrocytoma
RecruitingPhase 1/2
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
Low-Grade Glioma, Recurrent Low-Grade Glioma
Active, not recruitingPhase 2
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma
RecruitingPhase 2
Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
Anaplastic Astrocytoma, IDH-Wildtype, Anaplastic Oligoastrocytoma
Active, not recruitingPhase 1
Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligoastrocytoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide in people with Oligodendroglioma; Oligoastrocytoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate of the BCNU-TMZ combination administered before radiotherapy (time frame: At the end of Cycle 2 (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.