Glioblastoma multiforme. Malignant neoplasm of brain
Conditions
Interventions
Intervention 1: Intervention group: The standard radiation therapy regimen will be performed in 30 sessions with a total dose of 60 Gy (2 Gy per session). Also, chemotherapy regimen with temuzolamide
Sponsors
National Institute for Medical Research Development (NIMAD)
Sobhan Oncology Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age of 18 years and more Has newly diagnosis of GBM as determined by MRI findings. Tumors of deep and non-surgical areas Candidate for non-surgical treatment or biopsy
Exclusion criteria
Exclusion criteria: Age under 18 years Pregnancy Breastfeeding Hepatic or renal dysfunction Infection Concomitant with other brain diseases Existence of metastasis Psychosis and cognitive impairment Autoimmune diseases Patients undergoing brain surgery Ischemic heart disease Receiving other chemotherapy drugs or immunosuppressants during the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, all the adverse event of nilotinib will be recorded based on the Common Terminology Criteria for Adverse Events (CTCAE). Timepoint: 1. Weekly in radiation phase 2. Every four weeks in chemotherapy phase. Method of measurement: Blood tests, including a complete blood cell count, creatinine and blood urea, creatine phosphokinase, and liver function test, echocardiography, and electrocardiogram every. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival. Timepoint: Every 4 weeks. Method of measurement: History taking.;Progression-free survival. Timepoint: Every 3 months. Method of measurement: Brain MRI with contrast.;Karnofski performance score. Timepoint: Every 4 weeks. Method of measurement: Monthly visit with KPS questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEhsan Jangholi
Tehran University of Medical Sciences
Outcome results
None listed