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

Study Overview
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Brief Summary
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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.

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

Conditions
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Oligodendroglioma; Oligoastrocytoma

Intervention / Treatment
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* Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Administration of 6 cycles of chemotherapy | Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, chemotherapy, BCNU-Temozolomide