NCT03181477Active, not recruiting
Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 7 Jun 2017
- Start date
- 7 Apr 2017
- Primary completion date
- 2 Sept 2023
- Lead sponsor
- Centre Georges Francois Leclerc
- Diseases
- Glioblastoma
- NCT number
- NCT03181477
What you commit to
- Study type: Interventional
- Participants enrolled: 67
- From 7 Apr 2017 to the primary completion date, 2 Sept 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient must not have received radiation therapy or previous chemotherapy for this condition.
Other
- 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 ...).
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Centre d'oncologie et de radiothérapie Coordinator of this site? Confirm its status | Mâcon | France | Unknown status |
| Institut de cancérologie de Lorraine Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Paul Strauss Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Centre de cancérologie des dentellières Coordinator of this site? Confirm its status | Valenciennes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.