IDH-Wildtype GlioblastomaTMZ-CHRONONCT06850766
The Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma
A study testing Morning administration of TMZ and Evening administration of TMZ in people with IDH-Wildtype Glioblastoma and Glioblastoma (GBM), run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
The body's biological functions follow a circadian rhythm, meaning that individual biological functions in the body change over a 24-hour cycle. There is evidence suggesting that the body and cancer cells may react differently to anti-cancer treatment based on the time of day they are exposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDH-Wildtype Glioblastoma, Glioblastoma (GBM)
- What is being tested?
- Morning administration of TMZ and Evening administration of TMZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 8 May 2025to Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Newly diagnosed IDH-wildtype glioblastoma
- Completed maximal safe brain tumor resection
- Completed post-operative brain RT
- Plan to proceed with up to 6 cycles of adjuvant TMZ within 8 weeks of completing post-operative RT
- Able and willing to provide oral informed consent
Who cannot join
- Unable or unwilling to complete study questionnaires
- Metastatic or incurable cancer other than IDH-wild type glioblastoma
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Seth Climans, MD, 519-685-8600
Seth Climans, MD
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Lisa Vandermeer, MSc, 613-737-7700, lvandermeer@ohri.ca
Terry Ng, MD
About this study
Official title: A Randomized, Multicentre Pilot Trial Evaluating the Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma
The body's biological functions follow a circadian rhythm, meaning that individual biological functions in the body change over a 24-hour cycle. There is evidence suggesting that the body and cancer cells may react differently to anti-cancer treatment based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. Temozolomide (TMZ) is a chemotherapy pill/capsule commonly given to patients with newly diagnosed glioblastoma after brain surgery and radiation treatment. However, there is no current standard for what time of day TMZ should be taken for the treatment of glioblastoma.
In the current study, participants are randomly placed in one of two groups: a morning group and an evening group. Based on this group placement, participants are instructed to either take their TMZ in the morning or in the evening and record the date and time they take their TMZ in a pill diary. Participants will wear a wrist actigraphy device for the first cycle of TMZ. The primary goal of the study is to understand if taking TMZ at a prescribed time of day (morning/evening) is feasible in adults with glioblastoma. This is a pilot trial, and the investigators hypothesize that it will be feasible for glioblastoma patients to take TMZ at the prescribed time of day. The secondary goals of this study are to evaluate participant recruitment, safety, health-related quality of life, biological timing of TMZ delivery, and changes in condition over time. This pilot study will help investigators plan for a larger, pragmatic randomized clinical trial in the future.
Read the detailed description
TMZ-CHRONO is a randomized, multi-centre pilot trial evaluating the feasibility of chronotherapy (dose-timing) for temozolomide (TMZ) in IDH-wildtype glioblastoma (GBM).
The body's biological functions follow a circadian rhythm. Chronotherapy is the deliberate timing of medications to enhance therapeutic benefit and/or minimize toxicity, and can be achieved by dose-timing treatments. There is evidence suggesting that cancer cells may react differently to chemotherapy based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. TMZ is a standard of care treatment for GBM, however there is currently no consensus or guideline with respect to the optimal timing of adjuvant TMZ administration. The study team recently conducted systematic review on TMZ chronotherapy in the treatment of glioma. With emerging evidence that TMZ timing may be important, it is paramount to conduct a large pragmatic randomized study to assess this claim in GBM. The current study is a minimal risk pilot trial to inform the development of a larger, pragmatic randomized clinical trial in the future.
Prospective participants will be approached by their physician (or a member within the circle of care) during their routine clinic visit to begin the integrated verbal consent model process. The physician will explain that the patient is receiving standard of care treatment, with the only change being the timing of adjuvant TMZ (morning vs evening). The physician will then ask the patient for verbal consent to participate in this research study and document this consent in the patient's electronic medical record. Eligible and consenting patients will be randomized to one of two study arms (morning administration of TMZ, and evening administration of TMZ) in a 1:1 fashion using a permuted block design through the Ottawa Methods Centre. Randomization will be stratified by cancer centre [The Ottawa Hospital Cancer Centre (TOHCC) and the London Health Sciences Centre (LHSC); Canada]. The participants and investigators will not be blinded to treatment arm allocations. The participants will wear a wrist actigraphy device during the first cycle of TMZ.
The primary aim of the study is to understand if taking TMZ at a prescribed time of day (morning/evening) is feasible in adults with GBM. The secondary aims of the study are to evaluate participant recruitment, safety, health-related quality of life, biological timing of TMZ deliver, and changes in condition over time. Data is collected throughout the study at baseline, randomization, pre/post-TMZ cycles, and at 4-, 8-, 12-, 24-, and 48-weeks after baseline. The study team will continue to follow the participant conditions after TMZ completion for up to 5 years.
This pilot trial is the first and necessary step to assess the feasibility of randomized treatment allocation, rate of pill diary completion, and metrics surrounding participant accrual. This will help determine the number of recruitment sites and expected duration of accrual for a future pragmatic, randomized clinical trial on chronotherapy of TMZ in IDH-wildtype GBM.
- Conditions
- IDH-Wildtype Glioblastoma, Glioblastoma (GBM)
- Being tested
- Morning administration of TMZ, Evening administration of TMZ
- Keywords
- temozolomide, chronotherapy, dose timing, cancer, oncology, glioblastoma, chemotherapy
- Medical subject headings
- Glioblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning administration of TMZOther
Administration of TMZ within 2 hours of waking
Evening administration of TMZOther
Administration of TMZ within 2 hours of bedtime
| Study group | Role | What they receive |
|---|---|---|
| Morning administration of TMZ | Active comparator | Participants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the morning. Receives: Other: Morning administration of TMZ |
| Evening administration of TMZ | Active comparator | Participants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the evening. Receives: Other: Evening administration of TMZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: adherence to TMZ dose timing protocol
The primary outcome is feasibility for patients to receive temozolomide (TMZ) according to their assigned dose timing. Feasibility is measured by at least 80% adherence to the assigned TMZ dose timing. Adherence is calculated based on patient entries in a daily pill diary.
Measured: Patients complete daily pill diaries on days 1-5 of a 28-day cycle for up to 6 cycles. It is expected that the first cycle will begin within 8 weeks of the last fraction (dose) of radiation. Adherence is calculated at Week 48.
Secondary outcomes (16)
Participant recruitment: proportion of patients providing consent to participate
The number of patients who provided consent for study participation over the total number of patients approached and invited to participate in the clinical study
Measured: 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.
Participant recruitment: participant withdrawal rate and reasons
Proportion of eligible patients who consented to the study, but subsequently withdrew from study prior to starting the first cycle of adjuvant temozolomide (TMZ)
Measured: Withdrawal rate and reasons will be collected from enrollment to start of adjuvant TMZ
Participant recruitment: rate of patient enrollment
The rate of patient enrollment is defined by the number of new study participants who were randomized per center (average number of patients per month)
Measured: The number of patients enrolled in the study will be collected during the recruitment period. The anticipated recruitment period is one year.
Safety: rate of hospital admissions
Rate of hospital admissions per patient defined as the number of discrete admissions to acute care facility.
Measured: The number of hospitalizations will be collected from the start of adjuvant TMZ until 6 weeks after the last TMZ cycle (28-day cycles for up to 6 cycles). The number of hospitalizations per participant will be calculated at Week 48.
Safety: number of TMZ cycles
The median number of cycles received per group
Measured: The number of TMZ cycles will be calculated at Week 48, once all questionnaires and adjuvant treatment cycles are complete.
Safety: reasons for early discontinuation of adjuvant TMZ
The reasons for early discontinuation of adjuvant TMZ, if applicable, will be collected as a safety outcome.
Measured: The reasons for early discontinuation of adjuvant TMZ will be collected during the treatment period: post-cycle 1, post-cycle 2, post-cycle 3, post-cycle 4, post-cycle 5. Each TMZ cycle is 28 days.
Safety: rate of TMZ delay
The rate of TMZ delay due to not meeting treatment parameters will be collected as a safety outcome.
Measured: TMZ delay is collected during the treatment period: post-cycle 1, post-cycle 2, post-cycle 3, post-cycle 4, post-cycle 5. Each TMZ cycle is 28 days. The rate of TMZ delay is calculated at Week 48.
Health-related quality of life (HR-QoL): FACT-Br Version 4
HR-QoL will be measured according to the Functional Assessment of Cancer Therapy -- Brain (FACT-Br) version 4. The FACT-Br includes five subscales: physical well-being (score range 0-28), social/family well-being (score range 0-28), emotional well-being (score range 0-24), functional well-being (score range 0-28), and brain cancer subscale (score range 0-92). The FACT-Br total scores range from 0 to 200. Higher scores indicate better quality of life.
Measured: Baseline and 4-, 8-, 12-, 24-, and 48-weeks after baseline.
HR-QoL: Time to HR-QoL deterioration
Time to health-related quality of life deterioration based on the Functional Assessment of Cancer Therapy - Brain (FACT-Br Version 4) Trial Outcome Index. The FACT-Br Trial Outcome Index includes physical well-being, functional well-being and brain subscales. The scores range from 0 to 148 and higher score indicate better quality of life.
Measured: FACT-Br is collected at baseline and 4-, 8-, 12-, 24-, and 48-weeks after baseline..
Treatment-related side effects
Treatment related side effects are measured with modified Functional Assessment of Cancer Therapy - Brain items: GP1 lack of energy, GP2 nausea, GP5 bother by side effects. Each of the individual items are scored from 0 to 4, where higher scores indicate worse outcome.
Measured: Modified FACT-Br GP1, GP2, and GP5 are collected within 1 month of each TMZ cycle (28-day cycle). Post-cycle 1, post-cycle 2, post-cycle 3, post-cycle 4, post-cycle 5, post-cycle 6.
Change in Trial Outcome Index
Functional Assessment of Cancer Therapy - Brain (FACT-Br Version 4) Trial Outcome Index includes physical well-being, functional well-being and brain subscales. The FACT-Br Trial Outcome Index scores range from 0 to 148 and higher score indicate better quality of life. This outcome measure is a change in scores.
Measured: Baseline to 12-weeks
Change in FACT-Br scores
Change in mean Functional Assessment of Cancer Therapy - Brain (FACT-Br Version 4) scores from baseline between treatment groups. The FACT-Br total scores range from 0 to 200 and higher scores indicate better quality of life. This outcome measure is a change in scores.
Measured: FACT-Br is collected at baseline and 4-, 8-, 12-, 24-, and 48-weeks after baseline.
Time to first progression
Time to first progression is defined as the time from randomization to time of investigator-assessed disease progression.
Measured: Disease assessment occurs prior to each TMZ cycle. Each TMZ cycle is 28 days. There is a maximum of 6 cycles.
Overall survival
Overall survival (OS) is defined as the time from randomization to time of death. Time of death is collected through chart review and physician communications. Longitudinal follow-up will continue after completion of treatment until time of death or 5 years post-randomization for collection of overall survival data.
Measured: Overall survival is determined at 5-years after baseline.
Internal biological time of TMZ delivery
Daily internal biological time of TMZ delivery will be calculated based on actigraphy data (wrist movements in proportional integral mode) and clock timing of TMZ administration as recorded in the pill diary and with the actigraphy event marker.
Measured: Post-Cycle 1. Each cycle is 28 days in length.
Wall clock time of TMZ administration
Wall clock time of TMZ administration is determined by self-reported pill diary entries and the actigraphy event marker.
Measured: Post-Cycle 1. Each cycle is 28 days in length.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start8 May 2025
- Primary completionMay 2027 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IDH-Wildtype GlioblastomaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic pilot/feasibility trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Terry Ng, MD, Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850766
- Sponsor's protocol ID
- TMZ-CHRONO
- Acronym
- TMZ-CHRONO
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia JL, Alshamsan B, Ng TL. Temozolomide Chronotherapy in Glioma: A Systematic Review. Curr Oncol. 2023 Feb 4;30(2):1893-1902. doi: 10.3390/curroncol30020147.
PubMed 36826108
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicentre Pilot Trial Evaluating the Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma
- ClinicalTrials.gov ID
- NCT06850766
- Acronym / sponsor ID
- TMZ-CHRONO / TMZ-CHRONO
- Conditions
- IDH-Wildtype Glioblastoma, Glioblastoma (GBM)
- Keywords
- temozolomide, chronotherapy, dose timing, cancer, oncology, glioblastoma, chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- 8 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The body's biological functions follow a circadian rhythm, meaning that individual biological functions in the body change over a 24-hour cycle. There is evidence suggesting that the body and cancer cells may react differently to anti-cancer treatment based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. Temozolomide (TMZ) is a chemotherapy pill/capsule commonly given to patients with newly diagnosed glioblastoma after brain surgery and radiation treatment. However, there is no current standard for what time of day TMZ should be taken for the treatment of glioblastoma.
In the current study, participants are randomly placed in one of two groups: a morning group and an evening group. Based on this group placement, participants are instructed to either take their TMZ in the morning or in the evening and record the date and time they take their TMZ in a pill diary. Participants will wear a wrist actigraphy device for the first cycle of TMZ. The primary goal of the study is to understand if taking TMZ at a prescribed time of day (morning/evening) is feasible in adults with glioblastoma. This is a pilot trial, and the investigators hypothesize that it will be feasible for glioblastoma patients to take TMZ at the prescribed time of day. The secondary goals of this study are to evaluate participant recruitment, safety, health-related quality of life, biological timing of TMZ delivery, and changes in condition over time. This pilot study will help investigators plan for a larger, pragmatic randomized clinical trial in the future.
Detailed description
TMZ-CHRONO is a randomized, multi-centre pilot trial evaluating the feasibility of chronotherapy (dose-timing) for temozolomide (TMZ) in IDH-wildtype glioblastoma (GBM).
The body's biological functions follow a circadian rhythm. Chronotherapy is the deliberate timing of medications to enhance therapeutic benefit and/or minimize toxicity, and can be achieved by dose-timing treatments. There is evidence suggesting that cancer cells may react differently to chemotherapy based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. TMZ is a standard of care treatment for GBM, however there is currently no consensus or guideline with respect to the optimal timing of adjuvant TMZ administration. The study team recently conducted systematic review on TMZ chronotherapy in the treatment of glioma. With emerging evidence that TMZ timing may be important, it is paramount to conduct a large pragmatic randomized study to assess this claim in GBM. The current study is a minimal risk pilot trial to inform the development of a larger, pragmatic randomized clinical trial in the future.
Prospective participants will be approached by their physician (or a member within the circle of care) during their routine clinic visit to begin the integrated verbal consent model process. The physician will explain that the patient is receiving standard of care treatment, with the only change being the timing of adjuvant TMZ (morning vs evening). The physician will then ask the patient for verbal consent to participate in this research study and document this consent in the patient's electronic medical record. Eligible and consenting patients will be randomized to one of two study arms (morning administration of TMZ, and evening administration of TMZ) in a 1:1 fashion using a permuted block design through the Ottawa Methods Centre. Randomization will be stratified by cancer centre [The Ottawa Hospital Cancer Centre (TOHCC) and the London Health Sciences Centre (LHSC); Canada]. The participants and investigators will not be blinded to treatment arm allocations. The participants will wear a wrist actigraphy device during the first cycle of TMZ.
The primary aim of the study is to understand if taking TMZ at a prescribed time of day (morning/evening) is feasible in adults with GBM. The secondary aims of the study are to evaluate participant recruitment, safety, health-related quality of life, biological timing of TMZ deliver, and changes in condition over time. Data is collected throughout the study at baseline, randomization, pre/post-TMZ cycles, and at 4-, 8-, 12-, 24-, and 48-weeks after baseline. The study team will continue to follow the participant conditions after TMZ completion for up to 5 years.
This pilot trial is the first and necessary step to assess the feasibility of randomized treatment allocation, rate of pill diary completion, and metrics surrounding participant accrual. This will help determine the number of recruitment sites and expected duration of accrual for a future pragmatic, randomized clinical trial on chronotherapy of TMZ in IDH-wildtype GBM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic pilot/feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Morning administration of TMZ | Active comparator | Other: Morning administration of TMZParticipants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the morning. |
| Evening administration of TMZ | Active comparator | Other: Evening administration of TMZParticipants were instructed to take the prescribed daily dose of temozolomide (TMZ) in the evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Newly diagnosed IDH-wildtype glioblastoma
- Completed maximal safe brain tumor resection
- Completed post-operative brain RT
- Plan to proceed with up to 6 cycles of adjuvant TMZ within 8 weeks of completing post-operative RT
Key exclusion criteria (2 listed)
- Unable or unwilling to complete study questionnaires
- Metastatic or incurable cancer other than IDH-wild type glioblastoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning administration of TMZAdministration of TMZ within 2 hours of waking | Other | Morning administration of TMZ |
| Evening administration of TMZAdministration of TMZ within 2 hours of bedtime | Other | Evening administration of TMZ |
Primary outcome
Feasibility: adherence to TMZ dose timing protocol
Time frame: Patients complete daily pill diaries on days 1-5 of a 28-day cycle for up to 6 cycles. It is expected that the first cycle will begin within 8 weeks of the last fraction (dose) of radiation. Adherence is calculated at Week 48.
The primary outcome is feasibility for patients to receive temozolomide (TMZ) according to their assigned dose timing. Feasibility is measured by at least 80% adherence to the assigned TMZ dose timing. Adherence is calculated based on patient entries in a daily pill diary.
16 secondary outcomes
Participant recruitment: proportion of patients providing consent to participate
Time frame: 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.
Participant recruitment: participant withdrawal rate and reasons
Time frame: Withdrawal rate and reasons will be collected from enrollment to start of adjuvant TMZ
Participant recruitment: rate of patient enrollment
Time frame: The number of patients enrolled in the study will be collected during the recruitment period. The anticipated recruitment period is one year.
Safety: rate of hospital admissions
Time frame: The number of hospitalizations will be collected from the start of adjuvant TMZ until 6 weeks after the last TMZ cycle (28-day cycles for up to 6 cycles). The number of hospitalizations per participant will be calculated at Week 48.
Safety: number of TMZ cycles
Time frame: The number of TMZ cycles will be calculated at Week 48, once all questionnaires and adjuvant treatment cycles are complete.
Safety: reasons for early discontinuation of adjuvant TMZ
Time frame: The reasons for early discontinuation of adjuvant TMZ will be collected during the treatment period: post-cycle 1, post-cycle 2, post-cycle 3, post-cycle 4, post-cycle 5. Each TMZ cycle is 28 days.
Safety: rate of TMZ delay
Time frame: TMZ delay is collected during the treatment period: post-cycle 1, post-cycle 2, post-cycle 3, post-cycle 4, post-cycle 5. Each TMZ cycle is 28 days. The rate of TMZ delay is calculated at Week 48.
Health-related quality of life (HR-QoL): FACT-Br Version 4
Time frame: Baseline and 4-, 8-, 12-, 24-, and 48-weeks after baseline.
HR-QoL: Time to HR-QoL deterioration
Time frame: FACT-Br is collected at baseline and 4-, 8-, 12-, 24-, and 48-weeks after baseline..
Treatment-related side effects
Time frame: Modified FACT-Br GP1, GP2, and GP5 are collected within 1 month of each TMZ cycle (28-day cycle). Post-cycle 1, post-cycle 2, post-cycle 3, post-cycle 4, post-cycle 5, post-cycle 6.
Change in Trial Outcome Index
Time frame: Baseline to 12-weeks
Change in FACT-Br scores
Time frame: FACT-Br is collected at baseline and 4-, 8-, 12-, 24-, and 48-weeks after baseline.
Time to first progression
Time frame: Disease assessment occurs prior to each TMZ cycle. Each TMZ cycle is 28 days. There is a maximum of 6 cycles.
Overall survival
Time frame: Overall survival is determined at 5-years after baseline.
Internal biological time of TMZ delivery
Time frame: Post-Cycle 1. Each cycle is 28 days in length.
Wall clock time of TMZ administration
Time frame: Post-Cycle 1. Each cycle is 28 days in length.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 36826108Jia JL, Alshamsan B, Ng TL. Temozolomide Chronotherapy in Glioma: A Systematic Review. Curr Oncol. 2023 Feb 4;30(2):1893-1902. doi: 10.3390/curroncol30020147.
- The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terry Ng, MD principal investigator
The Ottawa Hospital Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning administration of TMZ and Evening administration of TMZ in people with IDH-Wildtype Glioblastoma and Glioblastoma (GBM), run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Vandermeer, MSc (613-737-7700, lvandermeer@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: adherence to TMZ dose timing protocol (time frame: Patients complete daily pill diaries on days 1-5 of a 28-day cycle for up to 6 cycles. It is expected that the first cycle will begin within 8 weeks of the last fraction (dose) of radiation. Adherence is calculated at Week 48.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.