NCT02781792 is a Phase 2 clinical trial of Temozolomide in Glioma, sponsored by Washington University School of Medicine.

Who is sponsoring NCT02781792?

NCT02781792 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT02781792?

Interventions in NCT02781792: Temozolomide, Functional Assessment of Cancer Therapy - Brain, ActTrust Condor Instrument Watch.

What condition does NCT02781792 study?

NCT02781792 studies Glioma, Glioblastoma Multiforme.

Is NCT02781792 still recruiting?

NCT02781792 is currently completed. Last updated 27 June 2025.

Are results published for NCT02781792?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-27 · How we verify

NCT02781792

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Temozolomide Chronotherapy for High Grade Glioma

Completed Phase 2 Results posted Last updated 27 June 2025

What this trial tests

Phase 2 trial testing Temozolomide in Glioma in 42 participants. Completed in 18 July 2024.

Timeline

11 August 2016

Primary endpoint
18 July 2024

18 July 2024

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	11 August 2016
Primary completion	18 July 2024
Estimated completion	18 July 2024
Sites	1 location across United States

Drugs / interventions tested

Temozolomide (temozolomide) — full drug profile →
Functional Assessment of Cancer Therapy - Brain
ActTrust Condor Instrument Watch

Conditions studied

Glioma — all drugs for Glioma →
Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Glioma or Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time Primary · 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.

Group	Value	95% CI
Arm 1: Temozolomide Morning	17
Arm 2: Temozolomide Evening	15

Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws Secondary · 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

Lymphopenia

Group	Value	95% CI
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	0

Thrombocytopenia

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	0

Neutropenia

Group	Value	95% CI
Arm 1: Temozolomide Morning	0
Arm 2: Temozolomide Evening	1

Anemia

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	0

Leukopenia

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	0

Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score Secondary · 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.

Baseline

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.23	± 4.17
Arm 2: Temozolomide Evening	4.80	± 4.27

Cycle 1

Group	Value	95% CI
Arm 1: Temozolomide Morning	5.78	± 4.96
Arm 2: Temozolomide Evening	4.00	± 2.83

Cycle 2

Group	Value	95% CI
Arm 1: Temozolomide Morning	7.66	± 6.92
Arm 2: Temozolomide Evening	8.32	± 5.65

Cycle 3

Group	Value	95% CI
Arm 1: Temozolomide Morning	7.33	± 5.67
Arm 2: Temozolomide Evening	7.69	± 5.31

Cycle 4

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.18	± 4.09
Arm 2: Temozolomide Evening	5.53	± 4.74

Cycle 5

Group	Value	95% CI
Arm 1: Temozolomide Morning	5.27	± 4.54
Arm 2: Temozolomide Evening	7.03	± 5.80

Cycle 6

Group	Value	95% CI
Arm 1: Temozolomide Morning	4.64	± 3.44
Arm 2: Temozolomide Evening	5.71	± 5.59

Cycle 7

Group	Value	95% CI
Arm 1: Temozolomide Morning	4.71	± 4.19
Arm 2: Temozolomide Evening	3.00	± 2.71

Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score Secondary · 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.

Baseline

Group	Value	95% CI
Arm 1: Temozolomide Morning	24.10	± 4.09
Arm 2: Temozolomide Evening	22.94	± 3.98

Cycle 1

Group	Value	95% CI
Arm 1: Temozolomide Morning	24.29	± 4.13
Arm 2: Temozolomide Evening	22.59	± 4.52

Cycle 2

Group	Value	95% CI
Arm 1: Temozolomide Morning	22.45	± 7.32
Arm 2: Temozolomide Evening	23.12	± 4.18

Cycle 3

Group	Value	95% CI
Arm 1: Temozolomide Morning	23.14	± 5.93
Arm 2: Temozolomide Evening	22.26	± 5.67

Cycle 4

Group	Value	95% CI
Arm 1: Temozolomide Morning	23.21	± 3.71
Arm 2: Temozolomide Evening	23.06	± 4.78

Cycle 5

Group	Value	95% CI
Arm 1: Temozolomide Morning	22.91	± 4.72
Arm 2: Temozolomide Evening	22.30	± 5.59

Cycle 6

Group	Value	95% CI
Arm 1: Temozolomide Morning	22.44	± 5.41
Arm 2: Temozolomide Evening	23.05	± 5.13

Cycle 7

Group	Value	95% CI
Arm 1: Temozolomide Morning	20.95	± 6.31
Arm 2: Temozolomide Evening	24.86	± 2.86

Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score Secondary · 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.

Baseline

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.72	± 3.72
Arm 2: Temozolomide Evening	7.60	± 3.19

Cycle 1

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.69	± 4.69
Arm 2: Temozolomide Evening	8.11	± 2.85

Cycle 2

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.06	± 4.82
Arm 2: Temozolomide Evening	6.77	± 2.10

Cycle 3

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.63	± 3.48
Arm 2: Temozolomide Evening	6.92	± 2.14

Cycle 4

Group	Value	95% CI
Arm 1: Temozolomide Morning	7.04	± 3.25
Arm 2: Temozolomide Evening	5.47	± 2.70

Cycle 5

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.68	± 1.82
Arm 2: Temozolomide Evening	5.36	± 2.01

Cycle 6

Group	Value	95% CI
Arm 1: Temozolomide Morning	6.23	± 3.45
Arm 2: Temozolomide Evening	5.57	± 1.51

Cycle 7

Group	Value	95% CI
Arm 1: Temozolomide Morning	7.29	± 2.56
Arm 2: Temozolomide Evening	5.14	± 2.73

Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score Secondary · 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.

Baseline

Group	Value	95% CI
Arm 1: Temozolomide Morning	18.19	± 6.39
Arm 2: Temozolomide Evening	16.35	± 7.06

Cycle 1

Group	Value	95% CI
Arm 1: Temozolomide Morning	18.71	± 7.09
Arm 2: Temozolomide Evening	15.89	± 7.59

Cycle 2

Group	Value	95% CI
Arm 1: Temozolomide Morning	15.94	± 8.68
Arm 2: Temozolomide Evening	16.11	± 7.17

Cycle 3

Group	Value	95% CI
Arm 1: Temozolomide Morning	16.37	± 5.59
Arm 2: Temozolomide Evening	17.69	± 5.86

Cycle 4

Group	Value	95% CI
Arm 1: Temozolomide Morning	17.75	± 6.82
Arm 2: Temozolomide Evening	18.78	± 6.93

Cycle 5

Group	Value	95% CI
Arm 1: Temozolomide Morning	17.32	± 7.23
Arm 2: Temozolomide Evening	19.27	± 7.86

Cycle 6

Group	Value	95% CI
Arm 1: Temozolomide Morning	18.64	± 7.66
Arm 2: Temozolomide Evening	20.00	± 7.28

Cycle 7

Group	Value	95% CI
Arm 1: Temozolomide Morning	18.71	± 6.34
Arm 2: Temozolomide Evening	23.57	± 5.77

Median Progression-free Survival (PFS) Secondary · 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.

Group	Value	95% CI
Arm 1: Temozolomide Morning	11.5978	7.1952 – 29.6680
Arm 2: Temozolomide Evening	8.1809	3.1869 – NA

Median Overall Survival Secondary · Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)

Group	Value	95% CI
Arm 1: Temozolomide Morning	26.9739	10.6121 – 44.3869
Arm 2: Temozolomide Evening	17.1831	8.3451 – NA

Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening Secondary · 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?"

Baseline

Group	Value	95% CI
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	4
Arm 1: Temozolomide Morning	4
Arm 2: Temozolomide Evening	2

Cycle 1

Group	Value	95% CI
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	3
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	2

Cycle 2

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	2
Arm 1: Temozolomide Morning	3
Arm 2: Temozolomide Evening	3

Cycle 3

Group	Value	95% CI
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	2
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	3

Cycle 4

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	0
Arm 1: Temozolomide Morning	3
Arm 2: Temozolomide Evening	5

Cycle 5

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	1
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	4

Cycle 6

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	0
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	3

Cycle 7

Group	Value	95% CI
Arm 1: Temozolomide Morning	1
Arm 2: Temozolomide Evening	0
Arm 1: Temozolomide Morning	2
Arm 2: Temozolomide Evening	1

\- Sleep Questionnaire: * Difficulty falling asleep/difficulty staying asleep/problem waking up too early: Answers range from 0=none, mild=1, moderate=2, severe=3, very=4. * How satisfied or dissatisfied are you with your current sleeping pattern question: Answers range from 0=very satisfied to 4=very dissatisfied. * To what extent do you consider your sleep problem to interfere with your daily functioning question: Answers range from 0=not at all interfering, 1=a little, 2=somewhat, 3=much, 4=very much interfering. * How noticeable to others do you think your sleep problem is in terms of imp

Difficulty falling asleep

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	1
Arm 1: Temozolomide Morning CYCLE 1	2
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	3
Arm 2: Temozolomide Evening CYCLE 2	2
Arm 1: Temozolomide Morning CYCLE 3	3
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	2
Arm 2: Temozolomide Evening CYCLE 4	4
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	4
Arm 1: Temozolomide Morning BASELINE	1
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	4
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	2
Arm 2: Temozolomide Evening BASELINE	1
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	2
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	0
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0

Difficulty staying asleep

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	4
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	2
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	3
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	3
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	3
Arm 2: Temozolomide Evening CYCLE 4	3
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	1
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	1
Arm 2: Temozolomide Evening CYCLE 2	3
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	4
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	3
Arm 1: Temozolomide Morning BASELINE	2
Arm 2: Temozolomide Evening BASELINE	1
Arm 1: Temozolomide Morning CYCLE 1	2
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	1
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0

Problem waking up too early

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	1
Arm 1: Temozolomide Morning CYCLE 1	3
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	3
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	4
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	2
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	4
Arm 1: Temozolomide Morning BASELINE	1
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	3
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	3
Arm 1: Temozolomide Morning CYCLE 5	3
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	2
Arm 2: Temozolomide Evening BASELINE	3
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	3
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	0
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0

How satisfied or dissatisfied are you with your current sleeping pattern?

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	0
Arm 1: Temozolomide Morning CYCLE 1	2
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	2
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	0
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	3
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	2
Arm 2: Temozolomide Evening CYCLE 4	2
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	2
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	3
Arm 1: Temozolomide Morning CYCLE 1	2
Arm 2: Temozolomide Evening CYCLE 1	3
Arm 1: Temozolomide Morning CYCLE 2	1
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	1

To what extent do you consider your sleep problem to interfere with your daily functioning?

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	3
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	2
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	1
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	4
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	3
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	2
Arm 1: Temozolomide Morning BASELINE	2
Arm 2: Temozolomide Evening BASELINE	1
Arm 1: Temozolomide Morning CYCLE 1	3
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	0
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	2
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0

How noticeable to others is your sleep problem is in terms of impairing the quality of your life

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	0
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	2
Arm 1: Temozolomide Morning CYCLE 3	2
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	2
Arm 2: Temozolomide Evening CYCLE 4	2
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	2
Arm 1: Temozolomide Morning BASELINE	1
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	2
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	3
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	2
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	3
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	3
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	2
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	2
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0

How worried or distressed are you about your current sleep problem?

Group	Value	95% CI
Arm 1: Temozolomide Morning BASELINE	3
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	2
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	2
Arm 1: Temozolomide Morning CYCLE 3	2
Arm 2: Temozolomide Evening CYCLE 3	1
Arm 1: Temozolomide Morning CYCLE 4	3
Arm 2: Temozolomide Evening CYCLE 4	3
Arm 1: Temozolomide Morning CYCLE 5	2
Arm 2: Temozolomide Evening CYCLE 5	3
Arm 1: Temozolomide Morning BASELINE	2
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	2
Arm 1: Temozolomide Morning CYCLE 2	2
Arm 2: Temozolomide Evening CYCLE 2	2
Arm 1: Temozolomide Morning CYCLE 3	2
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	1
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	1
Arm 1: Temozolomide Morning BASELINE	1
Arm 2: Temozolomide Evening BASELINE	2
Arm 1: Temozolomide Morning CYCLE 1	1
Arm 2: Temozolomide Evening CYCLE 1	1
Arm 1: Temozolomide Morning CYCLE 2	1
Arm 2: Temozolomide Evening CYCLE 2	1
Arm 1: Temozolomide Morning CYCLE 3	0
Arm 2: Temozolomide Evening CYCLE 3	2
Arm 1: Temozolomide Morning CYCLE 4	1
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	1
Arm 2: Temozolomide Evening CYCLE 5	0
Arm 1: Temozolomide Morning BASELINE	0
Arm 2: Temozolomide Evening BASELINE	0
Arm 1: Temozolomide Morning CYCLE 1	0
Arm 2: Temozolomide Evening CYCLE 1	0
Arm 1: Temozolomide Morning CYCLE 2	0
Arm 2: Temozolomide Evening CYCLE 2	0
Arm 1: Temozolomide Morning CYCLE 3	1
Arm 2: Temozolomide Evening CYCLE 3	0
Arm 1: Temozolomide Morning CYCLE 4	0
Arm 2: Temozolomide Evening CYCLE 4	0
Arm 1: Temozolomide Morning CYCLE 5	0
Arm 2: Temozolomide Evening CYCLE 5	0

Mean Circadian Amplitude Secondary · From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)

* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment. * Circadian amplitude, refers to the difference between the highest and lowest points of a circadian rhythm over a 24-hour cycle, is typically measured in the units of the rhythm being quantified. * The circadian mean amplitude was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.

AM Patient #1

Group	Value	95% CI
Arm 1: Temozolomide Morning	0.78	± 0.02

AM Patient #2

Group	Value	95% CI
Arm 1: Temozolomide Morning	0.78	± 0.01

PM Patient #1

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.81	± 0.01

PM Patient #2

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.78	± 0.01

PM Patient #3

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.77	± 0.02

PM Patient #4

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.81	± 0.01

Mean Sleep Regularity Index (SRI) Secondary · From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)

* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment. * Sleep regularity index (SRI) is the probability of being at rest, calculated per day for each patient. An SRI closer to 0 indicates irregular sleep patterns (i.e., more variable day to day), while values closer to 1 indicate regular sleep patterns. The SRI index scale is 0\~1. * The SRI was calculated per day for each patient with the mean and standard deviation report

AM Patient #1

Group	Value	95% CI
Arm 1: Temozolomide Morning	0.70	± 0.09

AM Patient #2

Group	Value	95% CI
Arm 1: Temozolomide Morning	0.79	± 0.8

PM Patient #1

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.82	± 0.09

PM Patient #2

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.69	± 0.10

PM Patient #3

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.68	± 0.08

PM Patient #4

Group	Value	95% CI
Arm 2: Temozolomide Evening	0.82	± 0.11

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) Adverse events were collected from start of treatment through end of treatment visit (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: Temozolomide Morning

Serious: 6/22 (27%)

Deaths: 7/22

Arm 2: Temozolomide Evening

Serious: 5/20 (25%)

Deaths: 6/20

Serious adverse events (12 terms)

Reaction	System	Arm 1: Temozolomide Morning	Arm 2: Temozolomide Evening
Death due to disease progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Aspartate aminotransferase increased	Investigations	—	—
Alanine aminotransferase increased	Investigations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Vascular access complication	Injury, poisoning and procedural complications	—	—
Pneumonia	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—
Seizure	Nervous system disorders	—	—
Lung infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Sepsis	Infections and infestations	—	—
Hydrocephalus	Nervous system disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Arm 1: Temozolomide Morning	Arm 2: Temozolomide Evening
Lymphocyte count decreased	Investigations	—	—
Anemia	Blood and lymphatic system disorders	—	—
Platelet count decreased	Investigations	—	—
White blood cell count decreased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—

Most-reported serious reactions: Death due to disease progression, Aspartate aminotransferase increased, Alanine aminotransferase increased, Fall, Vascular access complication, Pneumonia, Nausea, Seizure.

Data from ClinicalTrials.gov NCT02781792 adverse events section.

Sponsor's own description

Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy. Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas. Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Temozolomide chronotherapy in patients with glioblastoma: a retrospective single-institute study.
Damato AR, Luo J, Katumba RGN, Talcott GR, et al · · 2021 · cited 61× · PMID 33959716 · DOI 10.1093/noajnl/vdab041
Updates in IDH-Wildtype Glioblastoma.
Melhem JM, Detsky J, Lim-Fat MJ, Perry JR. · · 2022 · cited 55× · PMID 35641844 · DOI 10.1007/s13311-022-01251-6
Chronotherapy in Glioblastoma: state of the art and future perspectives.
Petković M, Henis M, Heese O, Relógio A. · · 2023 · cited 32× · PMID 36796229 · DOI 10.1016/j.ebiom.2023.104470
A randomized feasibility study evaluating temozolomide circadian medicine in patients with glioma.
Damato AR, Katumba RGN, Luo J, Atluri H, et al · · 2022 · cited 29× · PMID 35601970 · DOI 10.1093/nop/npac003
Adjusting the Molecular Clock: The Importance of Circadian Rhythms in the Development of Glioblastomas and Its Intervention as a Therapeutic Strategy.
Wagner PM, Prucca CG, Caputto BL, Guido ME. · · 2021 · cited 20× · PMID 34361055 · DOI 10.3390/ijms22158289
Personalized medicine and circadian rhythms: Opportunities for modern society.
Greco CM, Sassone-Corsi P. · · 2020 · cited 18× · PMID 32433754 · DOI 10.1084/jem.20200702
Circadian Rhythms of the Blood-Brain Barrier and Drug Delivery.
Kim M, Keep RF, Zhang SL. · · 2024 · cited 13× · PMID 38484027 · DOI 10.1161/circresaha.123.323521
Integration of circadian rhythms and immunotherapy for enhanced precision in brain cancer treatment.
Quist M, van Os M, van Laake LW, Bovenschen N, et al · · 2024 · cited 11× · PMID 39413708 · DOI 10.1016/j.ebiom.2024.105395

Verify or expand the search:

Other trials of Temozolomide

Trials testing the same drug.

NCT04373785 — NG101m Adjuvant Therapy in Glioblastoma Patients · Phase 1, PHASE2 · not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting
NCT07452458 — Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, ID · Phase 3 · not yet recruiting
NCT06639607 — PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/Hi · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Glioma

Currently open trials in the same condition.

NCT07486713 — Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies · Phase 4 · recruiting
NCT07236840 — Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors · recruiting
NCT07450872 — Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors · recruiting
NCT07405372 — Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas · recruiting
NCT07338539 — BIO-SHORT: Biologically Guided Short-Course Hypofractionated RT for Poor-Prognosis GBM · Phase 2 · recruiting

Other Washington University School of Medicine trials

Trials by the same sponsor.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02781792 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 27 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02781792.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02781792

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (12 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Temozolomide

Other recruiting trials for Glioma

Other Washington University School of Medicine trials

Verify against primary sources