Efficacy of two temozolomide regimens in adjuvant treatment of patients with brain malignant astrocytoma
Phase 3
Recruiting
- Conditions
- brain malignant astrocytoma.Malignant neoplasm of brain
- Registration Number
- IRCT20160706028815N3
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Newly diagnosed glioblastoma and anaplastic astrocytoma
age between 18 and 70 years
Karnofsky Performance Scale Index equal or more than 60 percent
signed informed consent
Exclusion Criteria
chronic hepatic, renal or cardiac failure
history of hematologic malignancies
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival. Timepoint: One year after the treatment is completed. Method of measurement: Patient follow-up.;Progression-free survival. Timepoint: 12 months after the treatment is completed. Method of measurement: brain imaging and physical examination.
- Secondary Outcome Measures
Name Time Method Anemia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of complete blood count.;Neutropenia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of complete blood count.;Thrombocytopenia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of complete blood count.;Alopecia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: physical examination.;Nausea. Timepoint: Before each session of monthly chemotherapy. Method of measurement: history taking.;Vomiting. Timepoint: Before each session of monthly chemotherapy. Method of measurement: history taking.