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Radiotherapy and chemotherapy with cisplatin and temozolomide for patients affected by primary glioblastoma of new diagnosis - ND

Radiotherapy and chemotherapy with cisplatin and temozolomide for patients affected by primary glioblastoma of new diagnosis - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000380-42-IT
Enrollment
Unknown
Registered
2009-01-22
Start date
2008-02-21
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Primary GLIOBLASTOMA of first diagnosis MedDRA version: 9.1 Level: PT Classification code 10018336 MedDRA version: 9.1 Level: SOC Classification code 10029205

Interventions

Trade Name: TEMODAL*1FL 5CPS 20MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Na

Sponsors

ISTITUTO NEUROLOGICO "CARLO BESTA"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: GBM of new diagnosis (histology). Age between 18 and 70 years. Karnofski Performance Status #8805; 70. Normal bone marrow, liver and kidney activity. No signs of active infection. Life expectancy > 12 weeks. Written 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: Prior radiotherapy Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: PFS-12 months;Secondary Objective: :Safety, Median Survival Time, Tumor response (radiological imaging);Primary end point(s): Progression-free survival (PFS) ( calcolato dalla data della exeresi)—

Countries

Italy

Outcome results

None listed

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