Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03181477 : Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas
PhaseN/A
AgesMin: 18 Years Max: 70 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03181477      |      Link to official Clinicaltrials.gov listing
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