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

Primary Purpose

Glioblastoma, Adult

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma, Adult focused on measuring Phase II, Radiotherapy with SIB-IMRT, Tomozolomide

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens Picardie
  • CHU Besançon
  • Centre Georges François Leclerc
  • Centre d'oncologie et de radiothérapie
  • Institut de cancérologie de Lorraine
  • Paul Strauss
  • Centre de cancérologie des dentellières

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

radiotherapy + chimiotherapy

Arm Description

Radiotherapy of 80 GY + Chemotherapy (Temozolomide)

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Full Information

First Posted
June 7, 2017
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
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1. Study Identification

Unique Protocol Identification Number
NCT03181477
Brief Title
Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas
Acronym
Glio-SIB-Up
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
September 2, 2023 (Actual)
Study Completion Date
September 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Adult
Keywords
Phase II, Radiotherapy with SIB-IMRT, Tomozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy + chimiotherapy
Arm Type
Other
Arm Description
Radiotherapy of 80 GY + Chemotherapy (Temozolomide)
Intervention Type
Device
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy of 80 GY + Chemotherapy (Temozolomide)
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Besançon
City
Besançon
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21850
Country
France
Facility Name
Centre d'oncologie et de radiothérapie
City
Mâcon
Country
France
Facility Name
Institut de cancérologie de Lorraine
City
Nancy
Country
France
Facility Name
Paul Strauss
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre de cancérologie des dentellières
City
Valenciennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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