Stereotactic accelerated radiotherapy concurrent with Temozolomide chemotherapy in newly diagnosed glioblastoma - ND

• Conditions: glioblastoma of new diagnosis; MedDRA version: 9.1Level: LLTClassification code 10018336

• Registration Number: EUCTR2009-015614-21-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

* Newly diagnosed supra-tentorial glioblastoma, surgically resected * Radiologically proved surgical resection of the tumor mass * Age between 18 and 65 years * Karnofski Performance Status ≥ 70 * Bone marrow, liver and kidney standard functionality * No concomitant infections * 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Brain neoplasia for which histological diagnosis is not available * Newly diagnosed glioblastoma, obtained by biopsy * Glioblastoma with dissemination subependimal * Tissue histology not available * Age > 65 and <18-aa * Karnofski Performance Status <70 * Severely impaired bone marrow function, liver, kidney * Co-infected * Pregnancy * Pregresso chemotherapy and / or radiotherapy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to evaluate if ipofractionated stereotactic radiotherapy associated with concomitant and adjuvant temozolomide chemotherapy has a statistically significant advantage in prolonging Progression Free Survival (PFS) when compared to the standard treatment (Stupp protocol).;Secondary Objective: Toxicity, PFS, Median Survival Time, local control of the tumor and overall survival; neurological toxicity. Tumor response will be assessed on MRI images after 2 months and every 3 months after that.;Primary end point(s): The primary endpoint of the study is evaluation of percentage of patients desease free at 12 months.