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)