Trial · NCT02125786

A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma

NCT02125786, Phase 2, Active not recruiting, St. Jude Children's Research Hospital; results first posted 2024-11-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma. Trials, record NCT02125786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02125786

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
NCT number: NCT02125786
Status: Active not recruiting
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Ependymoma
Interventions: Irradiation, Surgery, ^1^8F-Fluorodeoxyglucose, ^1^1C-methionine, Photon therapy, Proton therapy
First posted: 2014-04-29
Last updated: 2026-02-24
Results first posted: 2024-11-12

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	3-year Progression-free Survival Rate	2 years follow-up after initiation of radiation therapy for the last patient enrolled	To prospectively estimate the progression-free distribution for children and young adults with recurrent ependymoma treated with a second course of irradiation.
Primary	3-year Overall Survival Rate	2 years follow-up after initiation of radiation therapy for the last patient enrolled	OS was calculated from the date of initial radiation therapy to date of death or date of last contact for the patients who were treated with RT. The event of interest was death.
Secondary	Incidence Rate of Neurological Deficits	Through 5 years after initiation of second course of irradiation	Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcomes will be reported by p-values.
Secondary	Incidence Rate of Ophthalmological Deficits	Through 5 years after initiation of second course of irradiation	Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p values.
Secondary	Incidence Rate of Audiological Deficits	Through 5 years after initiation of second course of irradiation	Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p-values.
Secondary	Incidence Rate of Endocrine Deficits	Through 5 years after initiation of second course of irradiation	Evaluation will be in children and young adults with ependymoma treated with a second course of irradiation. Outcome will be reported with p-values.
Secondary	Number of Neurocognitive Deficits	Through 5 years after initiation of second course of irradiation
Secondary	Mean Change in Quality of Life by Treatment Arm	Baseline through 5 years after initiation of radiation therapy	Baseline is defined as day 1 of radiation therapy.
Secondary	Mean Change in Measured Task Sets	Baseline through 5 years after initiation of radiation therapy	Baseline is defined as day 1 of radiation therapy. Measured task sets: BOT2 (4-21 years old) and PPT (≥22 years old). * BOT2 outcome: total motor composite, a standardized score range from 20 to 80, with a mean of 50 and a standard deviation of 10. * PPT (7-item questionnaire) outcome: a score range from 0 to 28. The normative data is available from the human performance lab. The above scores will be standardized into z-scores/T-scores for data analysis based on normative data.
Secondary	Mean Change in Physical Function	Baseline through 5 years after initiation of radiation therapy	Baseline is defined as day 1 of radiation therapy. Self-reported instruments (PROMIS): Three questionnaires. * Pediatric Physical Function - Mobility - SF1: 8-item questionnaire with the score range from 0 to 32. * Pediatric Physical Function - Upper Extremity - SF1: same as above. * Physical Function - SF1: 10-item questionnaire with the score range from 0 to 50. The above scores will be standardized into z-scores/T-scores for data analysis based on normative data

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	3-year Progression-free Survival Rate	2 years follow-up after initiation of radiation therapy for the last patient enrolled	percentage of participants	NUMBER
PRIMARY	3-year Overall Survival Rate	2 years follow-up after initiation of radiation therapy for the last patient enrolled	percentage of participants	NUMBER
SECONDARY	Incidence Rate of Neurological Deficits	Through 5 years after initiation of second course of irradiation
SECONDARY	Incidence Rate of Ophthalmological Deficits	Through 5 years after initiation of second course of irradiation
SECONDARY	Incidence Rate of Audiological Deficits	Through 5 years after initiation of second course of irradiation
SECONDARY	Incidence Rate of Endocrine Deficits	Through 5 years after initiation of second course of irradiation
SECONDARY	Number of Neurocognitive Deficits	Through 5 years after initiation of second course of irradiation
SECONDARY	Mean Change in Quality of Life by Treatment Arm	Baseline through 5 years after initiation of radiation therapy
SECONDARY	Mean Change in Measured Task Sets	Baseline through 5 years after initiation of radiation therapy
SECONDARY	Mean Change in Physical Function	Baseline through 5 years after initiation of radiation therapy

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
3-year Progression-free Survival Rate	Reirradiation		21.88	95% Confidence Interval 12.73 to 32.61	percentage of participants
3-year Overall Survival Rate	Reirradiation		60.33	95% Confidence Interval 47.14 to 71.20	percentage of participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Reirradiation	68
Overall Study	COMPLETED	Reirradiation	9
Overall Study	NOT COMPLETED	Reirradiation	59

Source ClinicalTrials.gov

Adverse events17

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	Febrile neutropenia	Blood and lymphatic system disorders	Reirradiation	1	64	1
other	Sinus bradycardia	Cardiac disorders	Reirradiation	2	64	2
other	Sinus tachycardia	Cardiac disorders	Reirradiation	3	64	3
other	Other-Pseudomeningocele	General disorders	Reirradiation	1	64	1
other	Peripheral nerve infection	Infections and infestations	Reirradiation	1	64	1
other	Wound complication	Injury, poisoning and procedural complications	Reirradiation	1	64	1
other	Lymphocyte count decreased	Investigations	Reirradiation	2	64	2
other	Central nervous system necrosis	Nervous system disorders	Reirradiation	15	64	15
other	Cerebrospinal fluid leakage	Nervous system disorders	Reirradiation	1	64	1
other	Headache	Nervous system disorders	Reirradiation	1	64	1

1 to 10 of 17Source ClinicalTrials.gov

See all 17 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Reirradiation	8	64
Total, other adverse events	Reirradiation	30	64
Total, serious adverse events	Reirradiation	2	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02125786

GET https://conductscience.org/api/trials/v1/NCT02125786/registered?page=2

API reference For AI assistants