Glioblastoma. Malignant neoplasm of brain
Conditions
Interventions
Intervention 1: Neoadjuvant temozolomide 3 cycles 200 mg/m2 days 1-5 in a 28 days schedule, followed by chemoradiotherapy , 60 Gy radiotherapy single phase is administered in 2 Gy fractions over 6 we
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Histologically proven glioblastoma grade IV: GBM Age 18 - 80 years old Performance status WHO 0-2 Men and women of child bearing potential must be using adequate contraception Normal organ function, except if abnormal due to tumor involvement Patient
Exclusion criteria
Exclusion criteria: Prior chemotherapy or radiotherapy for malignant glioma Any other active malignancies within the last 5 years, except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ Pregnancy or breast feeding Any condition (medical, social, psychological) which would prevent adequate information and follow up Platelet count (TPK) 1.5 times the upper limit of normal (ULN) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) >3 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival. Timepoint: first MRI done 2-8 weeks after treatment and then within every 2-4 months interval for 3 years, every 3-6months after that, if any clinical symptoms presents follow out would take place in shorter intervals. Method of measurement: MRI Imaging changes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive changes. Timepoint: Before initiating treatment and then after completion of each therapeutic modality, 3 times for the control group and 4 times for the intervention group. Method of measurement: MMS (Mini-Mental State) examination test.;Hematologic complications. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Lab tests CBC.;Overall survival (OS). Timepoint: The date of the start of treatment until the time that patients are still alive. Method of measurement: time monthly.;Renal complications. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Lab tests BUN, Cr.;Hepatic complications. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Lab tests AST, ALT, ALKP.;Neurologic defects. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Weekly history taking presence or absence of seizure, headache, FND(focal neurological defect), dexamethasone usage. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Ghalehtaki
Tehran University of Medical Sciences
Outcome results
None listed