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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016813-11-IT
Enrollment
Unknown
Registered
2010-01-04
Start date
2010-01-22
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with histological diagnosis od glioblastoma in RPA class V and VI and age =>65 yrs. MedDRA version: 9.1 Level: SOC Classification code 10029104

Interventions

Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Sponsors

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026