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Alkylating agents

Temozolomide Timing for Glioblastoma (TMZ-CHRONO Trial)

London, Canada
N/A
Waitlist Available
Led By Terry Ng, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed post-operative brain RT
Completed maximal safe brain tumor resection
Must not have
Unable or unwilling to complete study questionnaires
Metastatic or incurable cancer other than IDH-wild type glioblastoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall survival is determined at 5-years post-randomization.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if taking a chemotherapy pill called Temozolomide (TMZ) at a specific time of day (morning or evening) is possible for adults with a type

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Who is the study for?
This trial is for adults with glioblastoma who have completed brain surgery and radiation. They must be able to take a chemotherapy pill called Temozolomide (TMZ) and keep a diary of when they take it. The study will exclude certain individuals based on criteria not specified here.Check my eligibility
What is being tested?
The study tests if the time of day TMZ is taken affects its effectiveness in treating glioblastoma. Participants are randomly assigned to take TMZ either in the morning or evening, and their health outcomes are monitored to plan for future larger trials.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical side effects of Temozolomide can include fatigue, nausea, constipation, headache, and potential blood-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished treatment for my brain with radiation after surgery.
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I've had surgery to remove as much of my brain tumor as safely possible.
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I am 18 years old or older.
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I have been newly diagnosed with a specific type of brain cancer.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot or do not want to fill out study questionnaires.
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My cancer is advanced and cannot be cured, but it's not IDH-wild type glioblastoma.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the number of patients providing consent to participate will be collected during the recruitment period and the total number/proportion will be calculated upon completion of recruitment. the anticipated recruitment period length is one year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the number of patients providing consent to participate will be collected during the recruitment period and the total number/proportion will be calculated upon completion of recruitment. the anticipated recruitment period length is one year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility: adherence to TMZ dose timing protocol
Secondary study objectives
Change in FACT-Br scores
Change in Trial Outcome Index
HR-QoL: Time to HR-QoL deterioration
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Morning administration of TMZActive Control1 Intervention
Participants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the morning.
Group II: Evening administration of TMZActive Control1 Intervention
Participants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the evening.

Find a Location

Closest Location:London Health Sciences Centre· London, Canada

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
583 Previous Clinical Trials
3,207,743 Total Patients Enrolled
1 Trials studying Glioblastoma
20 Patients Enrolled for Glioblastoma
The Ottawa HospitalOTHER
96 Previous Clinical Trials
63,992 Total Patients Enrolled
Terry Ng, MDPrincipal InvestigatorThe Ottawa Hospital Cancer Centre
2 Previous Clinical Trials
473 Total Patients Enrolled
~33 spots leftby Oct 2026