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NOT YET RECRUITING
NCT06477939
PHASE3

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

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

554

Start Date

2025-01-01

Completion Date

2032-12-31

Last Updated

2024-06-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Administration of L-TC

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.

OTHER

Radiotherapy plus Temozolomide

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.

Locations (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France