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

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.

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Key information

Conditions

Glioblastoma, Adult Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged from 18 to 70 years old.
Patients with a unifocal Glioblastoma (grade IV astrocytoma in the World Health Organization (WHO) classification) with postoperative macroscopic residue after biopsy or resection alone.
Location of the tumor or residual tumor, detected by Magnetic Resonance Imaging (MRI) sequences T1 gadolinium, more than 1cm from the optic chiasm
Diagnosis confirmed by pathology.
Time from surgery (if performed) and the start of radiation therapy less than 6 weeks.
performance status 0 or 1 in the WHO classification.
methylation status of the MGMT promoter gene requested
blood count: Neutrophil more than 1500/mm3 Platelets more than 100 000/mm3
Liver function test Bilirubin less than 1,5 times upper limit transaminases than 3 times upper limit
patient informed and informed consent signed
Possibility to trat by radiation withintensity modulated (fixed beams modulated or rotational modulation (TomoTherapy, dynamic arctherapy)) strictly respecting the constraints to organs at risk (Crystalline: 8 Gy max, Posterior chamber of the eye: 45 Gy max , optic nerve: 54 Gy max, chiasm: 54 Gy max, brain Stem: 2% 58 Gy D2 <64 Gy, Dmax <69 Gy spinal cord: 46 Gy max, healthy brain (brain - PTV): 60 Gy max 33%, 50 Gy to 50% and D100 <45 Gy to the brain in toto).
The patient must be affiliated to a social security scheme.

Exclusion criteria

Other histological "Glioblastoma".
Excision macroscopically complete individualized on postoperative MRI.
Patient unable to give consent.
A patient with against-indication to performed MRI (pacemaker, uncontrollable claustrophobia ...).
The patient must not have received radiation therapy or previous chemotherapy for this condition.
Other neoplasia unstabilized and / or treated for less than 5 years.
Patient already included in another clinical trial with an experimental molecule.
Inability to submit to medical monitoring testing for geographical, social or psychological.
Pregnancy or breastfeeding
Private Person of liberty under supervision or under curatorship
No affiliation to a social security scheme or medical state aid or the universal medical coverage

Treatment and study plan

Radiotherapy

Device

Radiotherapy of 80 GY + Chemotherapy (Temozolomide)

Primary outcomes

Overall survival

Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study 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

Acronym: Glio-SIB-Up

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2025
First posted: Jun 8, 2017
Registry last updated: Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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