High grade glioma: anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma
Conditions
Interventions
Trade Name: Temodal
Product Name: Temodal
Pharmaceutical Form: Capsule*
Trade Name: Belustine
Product Name: Belustine
Pharmaceutical Form: Capsule*
Sponsors
Dutch Childhood Oncology Group (DCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children with age =/> 3 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary localisation in the brain stem; M+ disease defined as evidence of neuraxis dissemination Karnovsky score 16 years; Landsky score < 50 in children =/< 16 years Life expectancy < 8 weeks Prior treatment other than surgery and corticiosteroids Abnormal organ functions Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine Event free Survival in children between 3 and 22 years old with newly diagnosed and biopsy prooven high grade glioma if treated according to this single arm phase II study: with concurrent radiation therapy and Temozolomide followed by Temozolomide and Lomustine (CCNU), compared to a historical control group;Secondary Objective: To determine toxicity of adjuvant treatment with Temozolomide and CCNU following radiation therapy and concurrent Temozolomide in a larger group of patients;Primary end point(s): Event free Survial | — |
Countries
Netherlands
Outcome results
None listed