Trial · NCT02781792
Temozolomide Chronotherapy for High Grade Glioma
NCT02781792, Phase 2, Completed, Washington University School of Medicine; results first posted 2025-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temozolomide Chronotherapy for High Grade Glioma. Trials, record NCT02781792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02781792
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide Chronotherapy for High Grade Glioma
- NCT number
- NCT02781792
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Glioma, Glioblastoma Multiforme
- Interventions
- Temozolomide, Functional Assessment of Cancer Therapy - Brain, ActTrust Condor Instrument Watch
- First posted
- 2016-05-24
- Last updated
- 2025-06-27
- Results first posted
- 2025-06-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time | Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles) | Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time. |
| Primary | Duration of Response | Through completion of follow-up (estimated to be 30 months) | * Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline \[JCO 28(11): 1963-1972, 2010\]. * The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
| Secondary | Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles) | * Lymphopenia grade 3 is \<500-200/mm\^3 and grade 4 is \<200/mm\^3 * Leukopenia grade 3 is \<2000-1000/mm\^3 and grade 4 is \<1000/mm\^3 * Neutropenia grade 3 is \<1000-500/mm\^3 and grade 4 is \<500/mm\^3 * Thrombocytopenia grade 3 is \<50,000-25,000/mm\^3 and grade 4 is \<25,000/mm\^3 * Anemia grade 3 is \<8.0-6.5 g/dL and grade 4 is \<6.5 g/dL |
| Secondary | Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | 7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range is 0-28. A higher score indicates a lower physical well-being quality of life. |
| Secondary | Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | 7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher social/family well-being quality of life. |
| Secondary | Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | 6-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-24. A higher score indicates a lower emotional well-being quality of life. |
| Secondary | Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | 7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher emotional well-being quality of life. |
| Secondary | Median Progression-free Survival (PFS) | Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
| Secondary | Median Overall Survival | Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) | |
| Secondary | Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | Sleep Questionnaire - 1 yes/no question of "do you have problems getting to sleep or staying asleep?" |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time | Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles) | Patients who received one full cycle of TMZ are evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of Response | Through completion of follow-up (estimated to be 30 months) | Data was not collected for this outcome measure. Duration of response was never listed as an objective in the protocol; however it was erroneously mentioned in the statistical analysis section of the protocol and therefore was listed as a primary outcome measure in error as well. | ||
| SECONDARY | Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point. | score on a scale | MEAN |
| SECONDARY | Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point. | score on a scale | MEAN |
| SECONDARY | Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point. | score on a scale | MEAN |
| SECONDARY | Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point. | score on a scale | MEAN |
| SECONDARY | Median Progression-free Survival (PFS) | Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) | months | MEDIAN | |
| SECONDARY | Median Overall Survival | Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) | months | MEDIAN | |
| SECONDARY | Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening | Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)) | Sleep questionnaires were only collected on 6 patients in each arm. If one of the 12 patients didn't complete a sleep questionnaire then they are not included in that timepoint. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group1,176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time | Arm 1: Temozolomide Morning | 17 | Participants | ||
| Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time | Arm 2: Temozolomide Evening | 15 | Participants | ||
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 1: Temozolomide Morning | Lymphopenia | 2 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 2: Temozolomide Evening | Lymphopenia | 0 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 1: Temozolomide Morning | Thrombocytopenia | 1 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 2: Temozolomide Evening | Thrombocytopenia | 0 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 1: Temozolomide Morning | Neutropenia | 0 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 2: Temozolomide Evening | Neutropenia | 1 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 1: Temozolomide Morning | Anemia | 1 | Participants | |
| Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws | Arm 2: Temozolomide Evening | Anemia | 0 | Participants |
1 to 10 of 1,176Source ClinicalTrials.gov
See all 1,176 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Temozolomide Morning | 22 | |
| Overall Study | STARTED | Arm 2: Temozolomide Evening | 20 | |
| Overall Study | COMPLETED | Arm 1: Temozolomide Morning | 17 | |
| Overall Study | COMPLETED | Arm 2: Temozolomide Evening | 15 | |
| Overall Study | NOT COMPLETED | Arm 1: Temozolomide Morning | 5 | |
| Overall Study | NOT COMPLETED | Arm 2: Temozolomide Evening | 5 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm 1: Temozolomide Morning | 1 | 22 | |
| other | Anemia | Blood and lymphatic system disorders | Arm 2: Temozolomide Evening | 0 | 20 | |
| other | Platelet count decreased | Investigations | Arm 1: Temozolomide Morning | 1 | 22 | |
| other | Platelet count decreased | Investigations | Arm 2: Temozolomide Evening | 0 | 20 | |
| other | White blood cell count decreased | Investigations | Arm 1: Temozolomide Morning | 1 | 22 | |
| other | White blood cell count decreased | Investigations | Arm 2: Temozolomide Evening | 0 | 20 | |
| other | Lymphocyte count decreased | Investigations | Arm 1: Temozolomide Morning | 2 | 22 | |
| other | Lymphocyte count decreased | Investigations | Arm 2: Temozolomide Evening | 0 | 20 | |
| other | Neutrophil count decreased | Investigations | Arm 1: Temozolomide Morning | 0 | 22 | |
| other | Neutrophil count decreased | Investigations | Arm 2: Temozolomide Evening | 1 | 20 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Temozolomide Morning | 7 | 22 |
| Total, all-cause mortality | Arm 2: Temozolomide Evening | 6 | 20 |
| Total, other adverse events | Arm 1: Temozolomide Morning | 4 | 22 |
| Total, other adverse events | Arm 2: Temozolomide Evening | 1 | 20 |
| Total, serious adverse events | Arm 1: Temozolomide Morning | 6 | 22 |
| Total, serious adverse events | Arm 2: Temozolomide Evening | 5 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35601970 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm 1: Temozolomide Morning vs Arm 2: Temozolomide Evening: Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time | Trial comparisons |
| Arm 1: Temozolomide Morning vs Arm 2: Temozolomide Evening: deaths from any cause | Trial comparisons |
| Arm 1: Temozolomide Morning vs Arm 2: Temozolomide Evening: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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