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NCT04755023: TEMOBIC
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
Phase 2 trial testing Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide in Oligodendroglioma; Oligoastrocytoma in 53 participants. Completed in 15 December 2010.
15 March 2009
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 21 December 2005 |
| Primary completion | 15 March 2009 |
| Estimated completion | 15 December 2010 |
| Sites | 1 location across France |
Drugs / interventions tested
- Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide — full drug profile →
Conditions studied
- Oligodendroglioma; Oligoastrocytoma — all drugs for Oligodendroglioma; Oligoastrocytoma →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
Adults 18 to 70, any sex, with Oligodendroglioma; Oligoastrocytoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04755023
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04755023 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 15 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04755023.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing