Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients
brief summary
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).
detailed description
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
official title
Phase III Randomized Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients to Evaluate Efficacy and Safety