Trial · NCT00027846
Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
NCT00027846, Phase 2, Completed, Children's Oncology Group; results first posted 2017-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma. Trials, record NCT00027846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00027846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
- NCT number
- NCT00027846
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 378 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Brain Tumor, Central Nervous System Tumor
- Interventions
- filgrastim, carboplatin, cyclophosphamide, etoposide, vincristine sulfate, radiation therapy, Mesna, therapeutic conventional surgery
- First posted
- 2003-01-27
- Last updated
- 2019-08-07
- Results first posted
- 2017-03-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | Up to 5 years after completion of study treatment | Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years. |
| Secondary | Overall Survival | Up to 5 years after completion of study treatment | Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years. |
| Secondary | Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy | At the time of second surgery | The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment. |
| Secondary | Event-free Survival (EFS) | At 5 years since the time of radiation therapy. | EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability. |
| Secondary | Event-free Survival (EFS) | At 5 years since the time of radiation therapy | EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years. |
| Secondary | Local Control and Patterns of Failure | Up to 5 years after completion of study treatment | Documented and analyzed qualitatively and quantitatively. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival | Up to 5 years after completion of study treatment | The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included. | Probability of EFS at 5 years | NUMBER |
| SECONDARY | Overall Survival | Up to 5 years after completion of study treatment | All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability. | Probability of OS at 5 years | NUMBER |
| SECONDARY | Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy | At the time of second surgery | Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%. | percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) | At 5 years since the time of radiation therapy. | Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability. | Probability of EFS at 5 years | NUMBER |
| SECONDARY | Event-free Survival (EFS) | At 5 years since the time of radiation therapy | Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. | Probability of EFS at 5 years | NUMBER |
| SECONDARY | Local Control and Patterns of Failure | Up to 5 years after completion of study treatment | All eligible patients in the study were included. | Participant | NUMBER |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival | GTR1 Differentiated Histology Supratentorial (Group 1) | 0.614 | 95% Confidence Interval 0.33 to 0.90 | Probability of EFS at 5 years | |
| Event-free Survival | Radiation (Group 2) | 0.685 | 95% Confidence Interval 0.63 to 0.74 | Probability of EFS at 5 years | |
| Event-free Survival | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 0.372 | 95% Confidence Interval 0.25 to 0.50 | Probability of EFS at 5 years | |
| Overall Survival | GTR1 Differentiated Histology Supratentorial (Group 1) | 1 | 95% Confidence Interval 1 to 1 | Probability of OS at 5 years | |
| Overall Survival | Radiation (Group 2) | 0.862 | 95% Confidence Interval 0.82 to 0.91 | Probability of OS at 5 years | |
| Overall Survival | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 0.702 | 95% Confidence Interval 0.58 to 0.82 | Probability of OS at 5 years | |
| Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 76 | 95% Confidence Interval 54.9 to 90.6 | percentage of participants | |
| Event-free Survival (EFS) | Differentiated Ependymoma | 0.424 | 95% Confidence Interval 0.27 to 0.58 | Probability of EFS at 5 years | |
| Event-free Survival (EFS) | Anaplastic Ependymoma | 0.298 | 95% Confidence Interval 0.05 to 0.54 | Probability of EFS at 5 years | |
| Event-free Survival (EFS) | Differentiated Ependymoma | 0.746 | 95% Confidence Interval 0.68 to 0.82 | Probability of EFS at 5 years |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GTR1 Differentiated Histology Supratentorial (Group 1) | 13 | |
| Overall Study | STARTED | Radiation (Group 2) | 287 | |
| Overall Study | STARTED | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 78 | |
| Overall Study | COMPLETED | GTR1 Differentiated Histology Supratentorial (Group 1) | 11 | |
| Overall Study | COMPLETED | Radiation (Group 2) | 219 | |
| Overall Study | COMPLETED | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 41 | |
| Overall Study | NOT COMPLETED | GTR1 Differentiated Histology Supratentorial (Group 1) | 2 | |
| Overall Study | NOT COMPLETED | Radiation (Group 2) | 68 | |
| Overall Study | NOT COMPLETED | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 37 |
Source ClinicalTrials.gov
Adverse events152
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 (Hgb) | Blood and lymphatic system disorders | Radiation (Group 2) | 0 | 281 | 0 |
| other | Hemoglobin (Hgb) | Blood and lymphatic system disorders | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 5 | 64 | 5 |
| other | Leukocytes (total WBC) | Investigations | Radiation (Group 2) | 16 | 281 | 18 |
| other | Leukocytes (total WBC) | Investigations | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 8 | 64 | 9 |
| other | Platelets | Investigations | Radiation (Group 2) | 0 | 281 | 0 |
| other | Platelets | Investigations | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 7 | 64 | 7 |
| other | Fatigue (lethargy, malaise, asthenia) | General disorders | Radiation (Group 2) | 0 | 281 | 0 |
| other | Fatigue (lethargy, malaise, asthenia) | General disorders | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 6 | 64 | 9 |
| other | Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) | General disorders | Radiation (Group 2) | 0 | 281 | 0 |
| other | Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) | General disorders | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 5 | 64 | 6 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation (Group 2) | ||
| Total, all-cause mortality | Sub-Total Resection Any Histology or Location (STR) (Group 3) | ||
| Total, other adverse events | Radiation (Group 2) | 52 | 281 |
| Total, other adverse events | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 27 | 64 |
| Total, serious adverse events | Radiation (Group 2) | 38 | 281 |
| Total, serious adverse events | Sub-Total Resection Any Histology or Location (STR) (Group 3) | 55 | 64 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Radiation (Group 2) vs Sub-Total Resection Any Histology or Location (STR) (Group 3): serious adverse events |
Source Trial comparisons
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/NCT00027846
GET https://conductscience.org/api/trials/v1/NCT00027846/results?page=2