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NCT03181477
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Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas

Sponsor: Centre Georges Francois Leclerc

View on ClinicalTrials.gov

Summary

Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four people per 100,000 inhabitants are diagnosed with this disease every year. The standard treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is 14.6 months \[13.2-16.8\]. In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions, associated with TMZ is feasible and well tolerated by patients with glioblastoma. The aim of this present phase II clinical trial is to evaluate the overall survival at 18 months for patients with glioblastoma receiving TMZ, according to standard protocol, associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions. Secondary objectives are tolerance, survival free progression and quality of live evaluations. Sixty seven patients will be enrolled in this present trial.

Official title: Multicenter Phase II Study Evaluating the Efficacy of Radiotherapy With Modulation Intensity and Integrated Boost (SIB-IMRT) at the Dose of 80Gy, Associated With Chemotherapy by Temozolomide in the Treatment of Adult Glioblastomas

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2017-04-07

Completion Date

2025-09-02

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

DEVICE

Radiotherapy

Radiotherapy of 80 GY + Chemotherapy (Temozolomide)

Locations (7)

CHU Amiens Picardie

Amiens, France

CHU Besançon

Besançon, France

Centre Georges François Leclerc

Dijon, France

Centre d'oncologie et de radiothérapie

Mâcon, France

Institut de cancérologie de Lorraine

Nancy, France

Paul Strauss

Strasbourg, France

Centre de cancérologie des dentellières

Valenciennes, France