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Efficacy of two temozolomide regimens in adjuvant treatment of patients with brain malignant astrocytoma

A single-blind, randomized, clinical trial comparing the efficacy of 6 cycles versus 12 cycles temozolomide regimens in adjuvant treatment of patients with brain malignant astrocytoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160706028815N3
Enrollment
62
Registered
2018-03-14
Start date
2018-03-21
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain malignant astrocytoma. Malignant neoplasm of brain

Interventions

Intervention 1: Intervention group 1 (12-cycle): After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters bod

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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

Exclusion criteria: chronic hepatic, renal or cardiac failure history of hematologic malignancies

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammadreza Saghafi

Mashhad University of Medical Sciences

SaghafiMR951@mums.ac.ir+98 51 3842 6936

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026