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Trial record 1 of 1 for:    GLIO-SIB-UP
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Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas (Glio-SIB-Up)

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ClinicalTrials.gov Identifier: NCT03181477
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

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.


Condition or disease Intervention/treatment Phase
Glioblastoma, Adult Device: Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : December 7, 2021
Estimated Study Completion Date : December 2, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
radiotherapy + chimiotherapy
Radiotherapy of 80 GY + Chemotherapy (Temozolomide)
Device: Radiotherapy
Radiotherapy of 80 GY + Chemotherapy (Temozolomide)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181477


Contacts
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Contact: Gilles TRUC +33 3 80 73 75 00 gtruc@cgfl.fr
Contact: Emilie REDERSTORFF +33 3 45 34 81 16 erederstorff@cgfl.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, France, 80054
Principal Investigator: Alexandre Dr COUTTE, MD         
Sub-Investigator: Mathieu Dr BOONE, MD         
CHU Besançon Recruiting
Besançon, France
Principal Investigator: Caroline Dr AMOYAL, MD         
Sub-Investigator: Gilles Dr TRUC, MD         
Sub-Investigator: Cédric Dr CHEVALIER, MD         
Centre Georges François Leclerc Recruiting
Dijon, France, 21850
Principal Investigator: Gilles Dr TRUC, MD         
Sub-Investigator: David Dr THIBOUW, MD         
Sub-Investigator: Magali Dr ROUFFIAC, MD         
Sub-Investigator: Noémie Dr VULQUIN, MD         
Sub-Investigator: Caroline Dr AMOYAL, MD         
Centre d'oncologie et de radiothérapie Not yet recruiting
Mâcon, France
Principal Investigator: Isabelle Dr POUCHARD, MD         
Sub-Investigator: Fabrice Dr LORCHEL, MD         
Sub-Investigator: Nicolas Dr BARBET, MD         
Institut de cancérologie de Lorraine Recruiting
Nancy, France
Principal Investigator: valérie Dr Bernier, MD         
Paul Strauss Recruiting
Strasbourg, France, 67000
Principal Investigator: Delphine Dr ANTONI, MD         
Sub-Investigator: Jean-Baptiste Dr CLAVIER, MD         
Sub-Investigator: Georges Dr NOEL, MD         
Sub-Investigator: Audrey Dr KELLER, MD         
Sub-Investigator: Clara Dr LE FEVRE, MD         
Centre de cancérologie des dentellières Recruiting
Valenciennes, France
Principal Investigator: Nicolas Dr BLANCHARD, MD         
Sub-Investigator: Frédérique Dr VASSEUR, MD         
Sub-Investigator: Anaïs Dr JOUIN, MD         
Sponsors and Collaborators
Centre Georges Francois Leclerc
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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03181477    
Other Study ID Numbers: 2016-A000679-42
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Georges Francois Leclerc:
Phase II
Radiotherapy with SIB-IMRT
Tomozolomide
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue