NCT03633552

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2018

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2021

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

July 20, 2018

Last Update Submit

August 13, 2018

Conditions

Glioblastoma Multiforme of BrainAnaplastic Astrocytoma of Brain

Keywords

Glioblastoma MultiformeAnaplastic AstrocytomaAdjuvant treatmentExtended chemotherapy

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    The time interval between the diagnosis and death.

    up to 1 year from start of treatment

  • Progression-free survival

    The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms

    up to 1 year from start of treatment

Secondary Outcomes (5)

  • Anemia

    monthly, up to 12 months during treatment

  • Neutropenia

    monthly, up to 12 months during treatment

  • Presence of alopecia

    monthly, up to 12 months during treatment

  • Presence of nausea

    monthly, up to 12 months during treatment

  • Presence of vomiting

    monthly, up to 12 months during treatment

Study Arms (2)

12-cycle arm

EXPERIMENTAL

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).

Drug: Temozolomide

6-cycle arm

ACTIVE COMPARATOR

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).

Drug: Temozolomide

Interventions

TemozolomideDRUG

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).

Also known as: Temodar, Temodal, Temcad, Glidar
12-cycle arm6-cycle arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • chronic hepatic
  • renal failure
  • cardiac failure
  • history of hematologic malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radiation ward of Emam Reza Hospital

Mashhad, Razavi Khorasan Province, 9137913316, Iran

RECRUITING

Omid Hospital

Mashhad, Razavi Khorasan Province, 917661377, Iran

RECRUITING

MeSH Terms

Conditions

GlioblastomaAstrocytoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mahdi Silanian Toosi, M.D.

    Mashhad University of Medical Sciences

    STUDY DIRECTOR

  • Kazem Anvari, M.D.

    Mashhad University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Seyed Alireza Javadinia, M.D.

CONTACT

00989155728157Javadiniaa941@mums.ac.ir

Mohammadreza Saghafi, M.D.

CONTACT

00989127898938SaghafiMR951@mums.ac.ir

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 16, 2018

Study Start

March 3, 2018

Primary Completion

March 3, 2021

Study Completion

April 3, 2021

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

IR(2)