Intensity Modulated Radiotherapy with Simultaneous Boost plus Temozolomide in high grade gliomas - ND
- Conditions
- high grade gliomasMedDRA version: 9.1Level: LLTClassification code 10018338Term: Glioma
- Registration Number
- EUCTR2008-003714-10-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- 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
? high grade (III-IV), with istological proven; ? age > 18 and < 80; ? ECOG 0-2. ? RPA class I-V ? Residual tumor max 8 cm
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
- no brain radiationtherapy - age < 18 years and > 80 years - RPA class VI - ECOG IV-V - Residual tumor > 8cm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Intensity Modulated Radiotherapy with Simultaneous Boost plus Temozolomide in high grade gliomas;Secondary Objective: ? progression free survival; ? acute toxicity ? late toxicity ? early responce to treatment with TC-Pet <br>;Primary end point(s): global survival
- Secondary Outcome Measures
Name Time Method