Overview

Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

Status:
Unknown status
Trial end date:
2021-04-03
Target enrollment:
0
Participant gender:
All
Summary
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mashhad University of Medical Sciences
Treatments:
Dacarbazine
Temozolomide
Criteria
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 failure

- cardiac failure

- history of hematologic malignancies