Randomized prospectic clinical trial Phase II in patients affected by prognostic class RPA V and VI glioblastoma: comparison between hypofractionated radiotherapy (RT) 30 Gy (6 fractions in two weeks) and esclusive temozolomide (TMZ)(200 mg/m2 for 5 days every 28) - AOBS-RT-TMZ
- Conditions
- Patients with histological diagnosis od glioblastoma in RPA class V and VI and age =>65 yrs.MedDRA version: 9.1Level: SOCClassification code 10029104
- Registration Number
- EUCTR2009-016813-11-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
- 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
histological diagnosis of glioblastoma prognostic classes RPA V and VI with age >= 65 yrs: Compliance to the treatment and to the follow-up; informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
Absence of histological diagnosis of glioblastoma age <65 yrs class RPA III-IV previous neoplasia excluding intraepithelial ca of portio previous brain radiotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Confront the impact of the two treatments in terms of disease response and quality of life.;Secondary Objective: 1. Evaluation of the time to progression 2. Evaluation of overall survival;Primary end point(s): 1. Evaluation of time to progression. 2. Evaluation of the quality adjusted survival according to method Murray 3. Evaluation of overall survival
- Secondary Outcome Measures
Name Time Method