Trial · NCT00114140
Temozolomide and Radiation Therapy in Treating Patients With Gliomas
NCT00114140, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Temozolomide and Radiation Therapy in Treating Patients With Gliomas. Trials, record NCT00114140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00114140
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide and Radiation Therapy in Treating Patients With Gliomas
- NCT number
- NCT00114140
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 136 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Temozolomide, Radiation therapy
- First posted
- 2005-06-14
- Last updated
- 2024-07-08
- Results first posted
- 2017-11-06
- Limitations and caveats
- Quality of life endpoint was added via an amendment while study was in progress.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Rate at 3 Years | Registration to 3 years | Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years. |
| Primary | Progression-free Survival | From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years. | Progressive Disease (PD) is defined as 25% or \> increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported. |
| Primary | Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Registration to 3 years | Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or \> increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. |
| Primary | Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Baseline, 6 months, and 12 months. | Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%. |
| Primary | Neurocognitive Function | Baseline, 6 months, and 12 months. | Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must "connect the dots" either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Rate at 3 Years | Registration to 3 years | Eligible patients | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival | From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years. | Eligible patients | years | MEDIAN |
| PRIMARY | Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Registration to 3 years | Eligible patients with O(6)-methylguanine-DNA methyltransferase (MGMT) status | years | MEDIAN |
| PRIMARY | Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Baseline, 6 months, and 12 months. | Eligible patients entered after QOL component amendment and alive at 6 and 12 months for respective post-baseline endpoints. | units on a scale | MEDIAN |
| PRIMARY | Neurocognitive Function | Baseline, 6 months, and 12 months. | Eligible patients entered after QOL component amendment with baseline score and alive at 6 and 12 months for respective timepoint. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Rate at 3 Years | Temozolomide + Radiation Therapy (RT) | 73.1 | 95% Confidence Interval 65.3 to 80.8 | percentage of participants | |
| Progression-free Survival | Temozolomide + Radiation Therapy (RT) | 4.5 | 95% Confidence Interval 3.5 to NA | years | |
| Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Temozolomide + Radiation Therapy (RT) - Methylated | Overall Survival | NA | 95% Confidence Interval 5.9 to NA | years |
| Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Temozolomide + Radiation Therapy (RT) - Unmethylated | Overall Survival | 3.0 | 95% Confidence Interval 2.3 to NA | years |
| Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Temozolomide + Radiation Therapy (RT) - Methylated | Progression-free Survival | NA | 95% Confidence Interval 4.5 to NA | years |
| Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Temozolomide + Radiation Therapy (RT) - Unmethylated | Progression-free Survival | 2.0 | 95% Confidence Interval 0.9 to 4.9 | years |
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Temozolomide + Radiation Therapy (RT) at Baseline | Physical Well-Being | 23 | Full Range 5.0 to 28.0 | units on a scale |
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Temozolomide + Radiation Therapy (RT) at 6 Months | Physical Well-Being | 22 | Full Range 3.0 to 28.0 | units on a scale |
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Temozolomide + Radiation Therapy (RT) at 12 Months | Physical Well-Being | 23 | Full Range 8.0 to 28.0 | units on a scale |
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Temozolomide + Radiation Therapy (RT) at Baseline | Social/Family Well-Being | 24.5 | Full Range 7.0 to 28.0 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Temozolomide + Radiation Therapy (RT) | 136 | |
| Overall Study | COMPLETED | Temozolomide + Radiation Therapy (RT) | 129 | |
| Overall Study | NOT COMPLETED | Temozolomide + Radiation Therapy (RT) | 7 |
Source ClinicalTrials.gov
Adverse events118
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 | Hemoglobin | Blood and lymphatic system disorders | Temozolomide + Radiation Therapy (RT) | 53 | 129 | |
| other | Hearing impaired | Ear and labyrinth disorders | Temozolomide + Radiation Therapy (RT) | 11 | 129 | |
| other | Ocular/visual - Other: | Eye disorders | Temozolomide + Radiation Therapy (RT) | 8 | 129 | |
| other | Vision blurred | Eye disorders | Temozolomide + Radiation Therapy (RT) | 10 | 129 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Temozolomide + Radiation Therapy (RT) | 7 | 129 | |
| other | Constipation | Gastrointestinal disorders | Temozolomide + Radiation Therapy (RT) | 61 | 129 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Temozolomide + Radiation Therapy (RT) | 27 | 129 | |
| other | Dry mouth | Gastrointestinal disorders | Temozolomide + Radiation Therapy (RT) | 11 | 129 | |
| other | Dyspepsia | Gastrointestinal disorders | Temozolomide + Radiation Therapy (RT) | 10 | 129 | |
| other | Gastrointestinal - Other: | Gastrointestinal disorders | Temozolomide + Radiation Therapy (RT) | 10 | 129 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide + Radiation Therapy (RT) | ||
| Total, other adverse events | Temozolomide + Radiation Therapy (RT) | 129 | 129 |
| Total, serious adverse events | Temozolomide + Radiation Therapy (RT) | 37 | 129 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29955793 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
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/NCT00114140
GET https://conductscience.org/api/trials/v1/NCT00114140/results?page=2