Role of initiating treatment with temozolomide in Glioblastoma

Phase 3

Recruiting

• Conditions: Glioblastoma.; Malignant neoplasm of brain

• Registration Number: IRCT20150929024266N5
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 134

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

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) <100 x 10^9/L
Hemoglobin (Hb) < 90 g/L
Neutrophils: < 1.5 x 10^3/mm3 or LPK < 3.0 x 10^9/L
Serum creatinine and bilirubin > 1.5 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) >3 x

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.