Trial · NCT01096368
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
NCT01096368, Phase 3, Completed, Children's Oncology Group; results first posted 2023-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma. Trials, record NCT01096368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01096368
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
- NCT number
- NCT01096368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 479 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Anaplastic Ependymoma, Brain Ependymoma, Cellular Ependymoma, Clear Cell Ependymoma, Ependymoma, Papillary Ependymoma
- Interventions
- 3-Dimensional Conformal Radiation Therapy, Carboplatin, Cisplatin, Clinical Observation, Cyclophosphamide, Etoposide, Filgrastim, Laboratory Biomarker Analysis, Mesna, Vincristine
- First posted
- 2010-03-31
- Last updated
- 2026-04-30
- Results first posted
- 2023-03-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of EFS are presented | Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. |
| Primary | Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. |
| Other | EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. |
| Other | EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. |
| Other | OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only. | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. |
| Other | OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. |
| Other | EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. |
| Other | OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy | Up to 10 years after enrollment. 5-year estimates of OS are presented. | The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. |
| Other | EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. |
| Other | OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation | Up to 10 years after enrollment. 5-year estimates of OS are presented. | The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of EFS are presented | Eligible, randomized participants (intent-to-treat) | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Eligible, randomized participants (intent-to-treat) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | Eligible, randomized participants (intent-to-treat) in stratum 1 (completely resected ependymom at initial surgery) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | Eligible, randomized participants (intent-to-treat) in stratum 2 (completely resected ependymom at initial surgery) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only. | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Eligible, randomized participants (intent-to-treat) in stratum 1 (completely resected ependymom at initial surgery) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Eligible, randomized participants (intent-to-treat) in stratum 2 (induction chemotherapy or second surgery required) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | Eligible participants in Arm IV (intent-to-treat) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Eligible participants in Arm IV (intent-to-treat) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation | Up to 10 years after enrollment. 5-year estimates of EFS are presented. | Eligible participants in Arm I | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation | Up to 10 years after enrollment. 5-year estimates of OS are presented. | Eligible participants in Arm I | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 69.2 | 95% Confidence Interval 60.8 to 76.2 | percentage of participants | |
| Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm III: Randomized to Radiation Only | 63.7 | 95% Confidence Interval 55.1 to 71.1 | percentage of participants | |
| Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 88.3 | 95% Confidence Interval 81.8 to 92.6 | percentage of participants | |
| Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm III: Randomized to Radiation Only | 86.9 | 95% Confidence Interval 79.8 to 91.6 | percentage of participants | |
| EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 1 | 72.7 | 95% Confidence Interval 63.8 to 79.8 | percentage of participants | |
| EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm III: Randomized to Radiation Only in Stratum 1 | 62.9 | 95% Confidence Interval 53.6 to 70.9 | percentage of participants | |
EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 41.7 | 95% Confidence Interval 17.9 to 64.0 | percentage of participants | |
EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only | Arm III: Randomized to Radiation Only in Stratum 2 | 67.5 | 95% Confidence Interval 41.4 to 84.0 | percentage of participants | |
| OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only. | Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 1 | 90.7 | 95% Confidence Interval 84.2 to 94.7 | percentage of participants | |
| OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only. | Arm III: Randomized to Radiation Only in Stratum 1 | 86.4 | 95% Confidence Interval 78.5 to 91.5 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Observation | 37 | |
| Overall Study | STARTED | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 167 | |
| Overall Study | STARTED | Arm III: Randomized to Radiation Only | 163 | |
| Overall Study | STARTED | Arm IV: Nonrandomly Assigned to Arm II Treatment | 63 | |
| Overall Study | STARTED | Not Ependymoma or Withdrew Before Radiation | 49 | |
| Overall Study | COMPLETED | Arm I: Observation | 37 | |
| Overall Study | COMPLETED | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 88 | |
| Overall Study | COMPLETED | Arm III: Randomized to Radiation Only | 154 | |
| Overall Study | COMPLETED | Arm IV: Nonrandomly Assigned to Arm II Treatment | 39 | |
| Overall Study | COMPLETED | Not Ependymoma or Withdrew Before Radiation | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events170
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 | Arm I: Observation | 0 | 37 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 0 | 164 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III: Randomized to Radiation Only | 0 | 161 | |
| other | Anemia | Blood and lymphatic system disorders | Arm IV: Nonrandomly Assigned to Arm II Treatment | 0 | 63 | |
| other | Anemia | Blood and lymphatic system disorders | Not Ependymoma or Withdrew Before Radiation | 1 | 24 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I: Observation | 0 | 37 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 1 | 164 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III: Randomized to Radiation Only | 0 | 161 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm IV: Nonrandomly Assigned to Arm II Treatment | 0 | 63 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Not Ependymoma or Withdrew Before Radiation | 1 | 24 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Observation | 0 | 37 |
| Total, all-cause mortality | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 20 | 164 |
| Total, all-cause mortality | Arm III: Randomized to Radiation Only | 27 | 161 |
| Total, all-cause mortality | Arm IV: Nonrandomly Assigned to Arm II Treatment | 22 | 63 |
| Total, all-cause mortality | Not Ependymoma or Withdrew Before Radiation | 4 | 24 |
| Total, other adverse events | Arm I: Observation | 0 | 37 |
| Total, other adverse events | Arm II: Randomized to Radiation With Maintenance Chemotherapy | 22 | 164 |
| Total, other adverse events | Arm III: Randomized to Radiation Only | 10 | 161 |
| Total, other adverse events | Arm IV: Nonrandomly Assigned to Arm II Treatment | 15 | 63 |
| Total, other adverse events | Not Ependymoma or Withdrew Before Radiation | 4 | 24 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | 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/NCT01096368
GET https://conductscience.org/api/trials/v1/NCT01096368/events?page=2