This is phase III randomized, multicenter study adding or not intra-venous Liposomal Trasncrocetin (L-TC) to hypofractionated radiotherapy and concomitant Temozolomide followed by adjuvant Temozolomide in patients with histologically confirmed diagnosis of glioblastoma (GBM).
During this trial the L-TC will be administered with the hypofractionated chemoradiation treatment to two cohorts: * Cohort 1 - Non-operable population defined as patients with age less than 70-year-old and with biopsy alone, Karnofski index we propose to use the L-TC with the hypofractionated chemoradiation treatment to two cohorts: * Cohort 2 - Elderly population defined as patients aged of more than 70-year-old and with Balducci score 1 or with low Balducci score 2 with Karnofski index ≥ 70% but whatever the quality of the surgery. For patients classified with a score of Balducci II, the geriatric assessment is essential. Although we are aware of the heterogeneity of patients in this group, we hope that the geriatric assessment will make it possible to reduce this heterogeneity by including only patients with a Charlson score \<4 and a score of autonomy IADL = 4 The eligible population will be randomized this combination with the treatment reference according to Perry et al publication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
554
Administration of L-TC (300 mg) as an IV perfusion, before each radiotion session Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week \+ Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days.
Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week \+ Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days.
Institut de cancérologie Strasbourg Europe
Strasbourg, France
Overall Survival
Overall Survival (OS) is defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death.
Time frame: Up to 24 months
Progression-Free Survival (PFS)
RANO criteria will be used to evaluate response
Time frame: Up to 24 months
Evaluation of hypoxia markers
Hypoxia imaging markers between two groups: comparison of volumetric metrics
Time frame: Up to 24 months
Quality of life
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire (QLQ-C30)
Time frame: Up to 24 months
Quality of life (GBM module)
EORTC 20-Item QOL-Brain Neoplasm (QLQ-BN20)
Time frame: Up to 24 months
Quality of life (specific for elderly population)
Quality-of-Life Questionnaire EORTC Elderly Cancer Patients (EORTC QLQ-ELD14)
Time frame: Up to 24 months
Tolerance
EORTC Elderly Cancer Patients (EORTC QLQ-ELD14)
Time frame: Up to 24 months
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