Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas (Glio-SIB-Up)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glioblastoma, Adult
• Intervention / Treatment: Device: Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens Picardie
  • Besançon, France
    • CHU Besançon
  • Dijon, France, 21850
    • Centre Georges Francois Leclerc
  • Mâcon, France
    • Centre d'oncologie et de radiothérapie
  • Nancy, France
    • Institut de Cancérologie de Lorraine
  • Strasbourg, France, 67000
    • Paul Strauss
  • Valenciennes, France
    • Centre de cancérologie des Dentellières

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: radiotherapy + chimiotherapy; Radiotherapy of 80 GY + Chemotherapy (Temozolomide)	Device: Radiotherapy; Radiotherapy of 80 GY + Chemotherapy (Temozolomide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	18 months

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Actual): September 2, 2023
• Study Completion (Estimated): September 2, 2025

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Phase II; Radiotherapy with SIB-IMRT; Tomozolomide
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 2016-A000679-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No