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

Phase 3

• Conditions: Glioblastoma Multiforme of Brain; Anaplastic Astrocytoma of Brain
• Interventions: Drug: Temozolomide

• Registration Number: NCT03633552
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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).

Detailed Description

This study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure. The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). 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). This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study. The primary endpoints of study are overall survival and progression free survival.

Study Timeline

• Study Start: 2018-03-03
• Study First Submitted: 2018-07-20
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-16
• Last Update Posted: 2018-08-16
• Primary Completion: 2021-03-03
• Study Completion: 2021-04-03

Recruitment & Eligibility

• Status: UNKNOWN
• 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 failure
• cardiac failure
• history of hematologic malignancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-cycle arm	Temozolomide	After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days).
6-cycle arm	Temozolomide	After completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days).

Primary Outcome Measures

Name	Time	Method
Progression-free survival	up to 1 year from start of treatment	The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms
Overall survival	up to 1 year from start of treatment	The time interval between the diagnosis and death.

Secondary Outcome Measures

Name	Time	Method
Anemia	monthly, up to 12 months during treatment	blood hemoglobin lower than 10 grams per deciliter
Neutropenia	monthly, up to 12 months during treatment	Blood almost mature neutrophils count lower than 1500/mm3
Presence of vomiting	monthly, up to 12 months during treatment	Eject matter from the stomach through the mouth.
Presence of alopecia	monthly, up to 12 months during treatment	A condition in which hair is lost
Presence of nausea	monthly, up to 12 months during treatment	An unpleasant sense of unease, discomfort, and revulsion towards food

Trial Locations

Locations (2)

Radiation ward of Emam Reza Hospital; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of

Omid Hospital; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of