Glioblastoma
Conditions
Keywords
IMRT, Radiotherapy escalation dose, glioblastoma, escalation radiotherapy dose
Brief summary
The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.
Interventions
RADIATIONradiotherapy
patients will receive from 6 to 7 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.
DRUGtemozolomide
patient will receive whatever the level 7 days a week, temozolomide at the dose of 75mg/m2 during radiotherapy period. They will then follow one month after the end the radiochemotherapy an adjuvant treatment corresponding to a 5 days treatments of temozolomide at the dose of 200mg/m2 every 28 days.
Sponsors
Ligue contre le cancer, France
Centre Georges Francois Leclerc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma) * Diagnosis must be obtained by a stereotactic or surgical biopsy * Age between 18 and 70 * Total or partial surgical resection deemed as not possible by a neurosurgeon * OMS performance status 0 or 1 * Adequate blood function : absolute neutrophil count \> 1.5 x 109/L, platelets count \> 100 x 109/L platelets; * Adequate liver function: bilirubin \< 1.5 ULN (upper limit of normal), ALT and AST \< 3 ULN, * Adequate renal function: creatinine \< 1.5 ULN * Patient must have been informed and must have signed the specific informed consent form.
Exclusion criteria
* other malignancy histology * resection of the brain tumor complete on MRI exploration * patient unable to give informed consent * patient presenting counter-indication to MRI exploration * patient must not have received neither radiotherapy nor chemotherapy for that affection * concomitant malignancy * patient already enrolled in another biomedical study with an experimental molecule * pregnant, nursing woman, or without contraception * private individuals of freedom or under tutelage (including legal guardianship) * psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma | 3 months after the start of the radiotherapy |
Countries
France
Outcome results
None listed