Status:
COMPLETED
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Oligodendroglioma; Oligoastrocytoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 propose...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04755023
Start Date
December 21 2005
End Date
December 15 2010
Last Update
February 15 2021
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13005