Status:
COMPLETED
Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of toleranc...
Eligibility Criteria
Inclusion
- giving their informed consent
- having a supratentorial malignant glioma, either grade 4 of St. Anne/Mayo grading, or glioblastoma multiforme according to WHO classification
- having an inoperable brain tumor (diagnosed by stereotactic biopsy)
- having a general status, evaluated by Karnofsky scale, \>60
- having a life expectancy \>3 months
- not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy
- potentially having another cancer, if histology and clinical history are available for comparison
- being able to take oral tablets
- no HIV disease
- satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils \>1500/mm3, platelets \>100000/mm3, Hb \>8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin \<1.5 times upper normal value, ASAT and ALAT \<3 times upper normal value
- for women of childbearing potential, a contraception is given
Exclusion
- having an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of St. Anne/Mayo grading
- having a Karnofsky score \<60
- having a life expectancy \<3 months
- having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy
- refusing any additional therapy
- having a non-malignant but serious systemic disease or uncontrolled active infection
- having a severe psychiatric disorder
- not having signed the informed consent
- pregnant or breastfeeding woman
Key Trial Info
Start Date :
February 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03310372
Start Date
February 13 2008
End Date
June 26 2012
Last Update
October 17 2017
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