Overview

Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Georges Francois Leclerc
Collaborator:
Ligue contre le cancer, France
Treatments:
Dacarbazine
Temozolomide
Criteria
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)