patients affected by glioblastoma multiforme MedDRA version: 9.1 Level: LLT Classification code 10018337
Conditions
Interventions
Trade Name: TEMODAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Temozolomide
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 75-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: .brainstem or spinal cord lesions. .previous brain radiotherapy .previous malignant neoplasm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 12 months- overall survival;Secondary Objective: Progression free survival. Toxicity. Quality of life.;Primary end point(s): 12 months- overall survival | — |
Countries
Italy
Outcome results
None listed