SIB-GBM trial (Simultaneous Integrated Boost in Glioblastoma multiforme: hyprofractionated radiotherapy with concomitant boost and temozolomide, in glioblastoma RPA III and IV patients - SIB-GBM trial
- Conditions
- patients affected by glioblastoma multiformeMedDRA version: 9.1Level: LLTClassification code 10018337
- Registration Number
- EUCTR2009-018258-43-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age > 18 years. Histological diagnosis of GBM RPA class III or IV preoperative brain MRI postoperative brain MRI Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
.brainstem or spinal cord lesions. .previous brain radiotherapy .previous malignant neoplasm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 12 months- overall survival;Secondary Objective: Progression free survival. Toxicity. Quality of life.;Primary end point(s): 12 months- overall survival
- Secondary Outcome Measures
Name Time Method