Trial · NCT00100802
Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
NCT00100802, Phase 2, Completed, Children's Oncology Group; results first posted 2017-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas. Trials, record NCT00100802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00100802
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
- NCT number
- NCT00100802
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 118 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Anaplastic Astrocytoma, Central Nervous System Neoplasm, Glioblastoma, Gliosarcoma, Spinal Cord Neoplasm
- Interventions
- Laboratory Biomarker Analysis, Lomustine, Radiation Therapy, Temozolomide
- First posted
- 2005-01-07
- Last updated
- 2023-02-15
- Results first posted
- 2017-01-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One Year Overall Survival | One year | Estimated one year survival using the Kaplan-Meier methodology. |
| Primary | Occurrence of Death Attributable to Complications of Protocol Therapy | While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy | Number of deaths due to complications of protocol therapy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | One Year Overall Survival | One year | Population is based on 106 eligible patients out of 118 patients enrolled. | Estimated probability | NUMBER |
| PRIMARY | Occurrence of Death Attributable to Complications of Protocol Therapy | While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy | 106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure. | patients | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| One Year Overall Survival | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 0.7208 | 95% Confidence Interval 0.6237 to 0.7968 | Estimated probability | |
| Occurrence of Death Attributable to Complications of Protocol Therapy | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | patients |
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 | Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up | 118 | |
| Overall Study | COMPLETED | Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up | 38 | |
| Overall Study | NOT COMPLETED | Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up | 80 |
Source ClinicalTrials.gov
Adverse events76
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 | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 26 | 106 | 26 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 5 | 106 | 5 |
| other | Hemolysis | Blood and lymphatic system disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Cushingoid | Endocrine disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Endocrine disorders - Other, specify | Endocrine disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Extraocular muscle paresis | Eye disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Eye disorders - Other, specify | Eye disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Papilledema | Eye disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
| other | Constipation | Gastrointestinal disorders | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 | 106 | 1 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | ||
| Total, other adverse events | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 83 | 106 |
| Total, serious adverse events | Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 3 | 106 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
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/NCT00100802
GET https://conductscience.org/api/trials/v1/NCT00100802/events?page=2