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

• Conditions: Primary GLIOBLASTOMA of first diagnosis; MedDRA version: 9.1Level: PTClassification code 10018336; MedDRA version: 9.1Level: SOCClassification code 10029205

• Registration Number: EUCTR2008-000380-42-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Prior radiotherapy Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)