Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Administration of 6 cycles of chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate of the BCNU-TMZ combination administered before radiotherapy | 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 | 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 | 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 | In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment | 1 month after radiotherapy |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Marseille | Marseille | 13005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33783067 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D002330 | Carmustine |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
Not provided
Not provided