A Phase II Study of Concurrent Radiation and Temozolomide Followed by Temozolomide and Lomustine (CCNU) in the Treatment of Children with High Grade Glioma
Phase 2
- Conditions
- High Grade Gliomamalignant Brain tumor10029211
- Registration Number
- NL-OMON30368
- Lead Sponsor
- Stichting Kinderoncologie Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
Cildren between 3 and 22 years of age, with a biopsy proven, newly diagnosed high grade glioma (anaplastic astrocytoma; glioblastoma multiforme; gliosarcoma) of the brain or spinal cord.
Exclusion Criteria
Primary high grade glioma of the brain stem; proved metastases; Karnofsky performance score < 50% for children > 16 years of age and Lansky < 50 for children = / < 16 years of age; life expectancy < 8 weeks; prior treatment other than surgery and corticosteroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Event Free Survival of patients compared to historical control cohorts.<br /><br>Toxicity measured according to standard scores.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>