Trial · NCT00077207
Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
NCT00077207, Not applicable, Completed, Children's Oncology Group; results first posted 2014-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma. Trials, record NCT00077207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00077207
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
- NCT number
- NCT00077207
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 66 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Brain Tumor, Central Nervous System Tumor
- Interventions
- carboplatin, temozolomide, vincristine sulfate
- First posted
- 2004-02-11
- Last updated
- 2018-05-16
- Results first posted
- 2014-07-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Short Term Feasibility Success | 24 weeks | Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure. |
| Primary | Long Term Feasibility Success | 60 weeks | Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success. |
| Secondary | Number of Participants Who Experienced Toxic Death | Up to 6 years after the start of protocol therapy | Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin. |
| Secondary | Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. | Up to 18 months of protocol therapy | Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy. |
| Secondary | Percent Probability of Progression-free Survival (PFS) | 3 years | Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment. |
| Secondary | Percentage Probability of Event-free Survival (EFS) | Six years | Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment. |
| Secondary | Total Number of Patients Experiencing a Response | Up to 18 months of protocol therapy | Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Short Term Feasibility Success | 24 weeks | Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient. | participants | NUMBER |
| PRIMARY | Long Term Feasibility Success | 60 weeks | Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient. | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Toxic Death | Up to 6 years after the start of protocol therapy | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. | Up to 18 months of protocol therapy | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Probability of Progression-free Survival (PFS) | 3 years | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Percent probability PFS | NUMBER |
| SECONDARY | Percentage Probability of Event-free Survival (EFS) | Six years | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | percent probability EFS | NUMBER |
| SECONDARY | Total Number of Patients Experiencing a Response | Up to 18 months of protocol therapy | Sixty-five (65) eligible patients were enrolled and received protocol therapy. Of these patients, 60 had data submission sufficient to determine response. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Short Term Feasibility Success | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 25 | participants | ||
| Long Term Feasibility Success | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 41 | participants | ||
| Number of Participants Who Experienced Toxic Death | Carboplatin, Vincristine Sulfate, Temozolomide) | 0 | Participants | ||
| Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. | Carboplatin, Vincristine Sulfate, Temozolomide) | 43 | Participants | ||
| Percent Probability of Progression-free Survival (PFS) | Carboplatin, Vincristine Sulfate, Temozolomide) | 60.59 | 95% Confidence Interval 47.48 to 71.40 | Percent probability PFS | |
| Percentage Probability of Event-free Survival (EFS) | Carboplatin, Vincristine Sulfate, Temozolomide) | 40.89 | 95% Confidence Interval 28.63 to 52.76 | percent probability EFS | |
| Total Number of Patients Experiencing a Response | Carboplatin, Vincristine Sulfate, Temozolomide) | Complete response | 2 | Participants | |
| Total Number of Patients Experiencing a Response | Carboplatin, Vincristine Sulfate, Temozolomide) | Partial response | 15 | Participants | |
| Total Number of Patients Experiencing a Response | Carboplatin, Vincristine Sulfate, Temozolomide) | Stable disease | 36 | Participants | |
| Total Number of Patients Experiencing a Response | Carboplatin, Vincristine Sulfate, Temozolomide) | Progressive disease | 7 | 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 | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 66 | |
| Overall Study | COMPLETED | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 36 | |
| Overall Study | NOT COMPLETED | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 30 |
Source ClinicalTrials.gov
Adverse events138
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 | Abdominal distension | Gastrointestinal disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 1 | 64 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 10 | 64 | |
| other | Acidosis | Metabolism and nutrition disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 10 | 64 | |
| other | Agitation | Psychiatric disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 3 | 64 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 19 | 64 | |
| other | Alkaline phosphatase increased | Investigations | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 7 | 64 | |
| other | Allergic reaction | Immune system disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 7 | 64 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 5 | 64 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 10 | 64 | |
| other | Anaphylaxis | Immune system disorders | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 7 | 64 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | ||
| Total, other adverse events | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 50 | 64 |
| Total, serious adverse events | Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) | 6 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25854526 | RESULT |
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.
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/NCT00077207
GET https://conductscience.org/api/trials/v1/NCT00077207/events?page=2