Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
- Conditions
- Glioblastoma Multiforme
- Interventions
- Radiation: Ultrafractionated brain irradiation
- Registration Number
- NCT03310372
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ultrafractionated brain irradiation - temozolomide Temozolomide - ultrafractionated brain irradiation - temozolomide Ultrafractionated brain irradiation -
- Primary Outcome Measures
Name Time Method partial response through study completion, 2 years defined by at least 50% diminution of tumor size, evaluated by the product of 2 perpendicular diameters measured by MRI, with stability or amelioration of neurological status of patient receiving stable or reduced corticoid doses
progression through study completion, 2 years defined by increase of at least 25% of tumor size and/or a second brain localization in MRI, with degradation of neurological status of patient
complete response through study completion, 2 years defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids
stabilization through study completion, 2 years corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses
- Secondary Outcome Measures
Name Time Method treatment tolerance through study completion, 2 years evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)
global survival through study completion, 2 years survival without tumor recurrence through study completion, 2 years tumor recurrence detected with radiology examination
life quality through study completion, 2 years evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30)