Trial · NCT00313729
Temozolomide in Treating Patients With Low-Grade Glioma
NCT00313729, Phase 2, Completed, University of California, San Francisco; results first posted 2019-01-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temozolomide in Treating Patients With Low-Grade Glioma. Trials, record NCT00313729. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00313729
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide in Treating Patients With Low-Grade Glioma
- NCT number
- NCT00313729
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- CNS Tumor, Adult
- Interventions
- temozolomide
- First posted
- 2006-04-12
- Last updated
- 2019-02-07
- Results first posted
- 2019-01-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Complete and Partial Response) | 12 months | Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids. |
| Secondary | Time to Tumor Progression | time from registration until date of the first documented progression, an average of 1 year | Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria. |
| Secondary | Safety Profile | Time from registration up to 13 months | Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (Complete and Partial Response) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Tumor Progression | time from registration until date of the first documented progression, an average of 1 year | years | MEDIAN | |
| SECONDARY | Safety Profile | Time from registration up to 13 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Complete and Partial Response) | Temozolomide | 7 | Participants | ||
| Time to Tumor Progression | Temozolomide | 3.8 | 95% Confidence Interval 3.0 to 5.0 | years | |
| Safety Profile | Temozolomide | 12 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm Study of Temozolomide for LGG Patients | 120 | |
| Overall Study | COMPLETED | Single Arm Study of Temozolomide for LGG Patients | 120 | |
| Overall Study | NOT COMPLETED | Single Arm Study of Temozolomide for LGG Patients | 0 |
Source ClinicalTrials.gov
Adverse events45
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 | Fatigue | Metabolism and nutrition disorders | Temozolomide | 9 | 120 | 18 |
| other | Nausea | Gastrointestinal disorders | Temozolomide | 11 | 120 | 17 |
| other | SGPT (ALT) (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Temozolomide | 5 | 120 | 6 |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Temozolomide | 1 | 120 | 1 |
| other | Seizures | Nervous system disorders | Temozolomide | 7 | 120 | 8 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Temozolomide | 4 | 120 | 5 |
| other | Tremor | Nervous system disorders | Temozolomide | 1 | 120 | 1 |
| other | Weight loss | Metabolism and nutrition disorders | Temozolomide | 2 | 120 | 2 |
| other | Anorexia | Gastrointestinal disorders | Temozolomide | 2 | 120 | 3 |
| other | Constipation | Gastrointestinal disorders | Temozolomide | 8 | 120 | 10 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide | ||
| Total, other adverse events | Temozolomide | 31 | 120 |
| Total, serious adverse events | Temozolomide | 17 | 120 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00313729
GET https://conductscience.org/api/trials/v1/NCT00313729/events?page=2