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

NCT ID: NCT04755023

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-21
• Study Completion Date: 2010-12-15

Brief 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.

Conditions

Oligodendroglioma; Oligoastrocytoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Administration of 6 cycles of chemotherapy

Group Type: EXPERIMENTAL

Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide

Intervention Type: 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.

Interventions

Bis-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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2004-30

Identifier Type: -

Identifier Source: org_study_id