Evaluating primary chemotherapy with temozolomide continuative low dose in patients with low grade gliomas grade II WHO - Continuative temozolomide in low grade gliomas
- Conditions
- First line chemotherapy in low grade gliomaMedDRA version: 6.1Level: PTClassification code 10060971
- Registration Number
- EUCTR2006-001545-34-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
Histologically proven low grade diffuse glioma Astrocytoma WHO grade II gemistocytic, fibrillary and protoplasmatic , Oligoastrocytoma WHO grade II and oligodendroglioma WHO II; Newly diagnosed; Requiring treatment as demonstrated by at least one of the following criteria 1. measurable disease after surgery or biopsy 2. Prior radiotherapy, if any, have to be completed at least 8 weeks before enrollment 3. Neurological symptoms others than seizures only focal deficits, signs of increased intracranial pressure, mental deficits ; 4. Intractable/drug-resistent seizures; 5. Age 40 years; Karnofsky PS 60; Adequate hematological, renal and hepatic function; No prior chemotherapy; Written informed consent 1p/19q FISH analysis
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
Recurrent/progressive low grade astrocytoma with histological or radiological signs of anaplastic progression.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method