Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477939
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Study of Adding or Not Liposomal Transcrocetin L-TC With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma GBM Patients
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THREE-GLEES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-515666-13-00 | CTIS | None | None |