Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme (TEMOFRAC)

Central Hospital, Nancy, France

Status and phase

Completed

Phase 2

Conditions

Glioblastoma Multiforme

Treatments

Drug: Temozolomide

Radiation: Ultrafractionated brain irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT03310372

2007-004968-41

Details and patient eligibility

About

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 tolerance and objective response rate.

The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.

Enrollment

46 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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