Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
radiotherapy + temozolomide
Radiotherapy:
dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3
dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3
Chemotherapy:
temozolomide given at the dose of 75mg/m2
Intervention: radiotherapy (Radiation)
radiotherapy + temozolomide
Radiotherapy:
dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3
dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3
Chemotherapy:
temozolomide given at the dose of 75mg/m2
Intervention: temozolomide (Drug)
Outcomes
Primary Outcomes
To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma
Time Frame: 3 months after the start of the radiotherapy
Secondary Outcomes
No secondary outcomes reported