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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03181477
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Georges Francois Leclerc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Adult

Arms & Interventions

Arms

Other: radiotherapy + chimiotherapy

Radiotherapy of 80 GY + Chemotherapy (Temozolomide)

Interventions

Device: - Radiotherapy

Radiotherapy of 80 GY + Chemotherapy (Temozolomide)

Contact a Trial Team

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