Clinical trial NCT03310372: Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
Official title: Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: complete response
timeFrame: through study completion, 2 years
measure: partial response
timeFrame: through study completion, 2 years
measure: stabilization
timeFrame: through study completion, 2 years
measure: progression
timeFrame: through study completion, 2 years
Secondary outcomes:
measure: global survival
timeFrame: through study completion, 2 years
measure: treatment tolerance
timeFrame: through study completion, 2 years
measure: survival without tumor recurrence
timeFrame: through study completion, 2 years
measure: life quality
timeFrame: through study completion, 2 years
Other outcomes:
Locations:
Study officials:
References: