Trial · NCT02125786
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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 |
| Secondary | Mean Change in Body Mass Index (kg/m2) | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy |
| Secondary | Mean Change in Waist/Hip Ratio (cm/cm) | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. |
| Secondary | Mean Change in Ankle Dorsiflexion | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Ankle dorsiflexion active and passive range of motion: measured by goniometer, and recorded as an angle (degree). |
| Secondary | Mean Change in Overall Flexibility in cm | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Overall flexibility: measured by sit and reach test, and recorded as a length (cm). |
| Secondary | Proportion Change in Balance | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Balance measured by Measured by sensory organization test (SOT), and the result from the test is the equilibrium score, a percentage range from 0% to 100%, with the higher percentage, the better balance. The outcome is a binary variable with a cutoff score of \< 70% indicates future risk for a fall. |
| Secondary | Mean Change in Fine Motor Coordination | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Fine motor coordination (finger and hand coordination). Measured by Composite Cerebellar Functional Severity Score (CCFS), and the outcome is an age-adjusted z-score and log transformed. |
| Secondary | Mean Change in Overall Coordination | Fine motor coordination (finger and hand coordination). | Baseline is defined as day 1 of radiation therapy. Overall coordination measured by brief ataxia rating scale (five-item questionnaire). The outcome is a total scale range from 0 to 22. |
| Secondary | Mean Change of Lower Extremity Strength and Power | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Lower extremity strength measured by BiodexIII. The outcomes are peak torque value/body weight ratios at different speeds of motion. The scores will be standardized into z-scores for data analysis based on normative data. |
| Secondary | Mean Change in Hand Grip Strength | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Hand grip strength is measured by a Jamar hand held dynamometer and recorded in kilograms (kg). The scores will be standardized into z-scores for data analysis based on normative data. |
| Secondary | Mean Change in Resting Energy Expenditure | Baseline through 5 years after initiation of radiation therapy | Baseline is defined as day 1 of radiation therapy. Resting energy expenditure is measured with indirect calorimetry after an overnight fast and recorded as REE (kcal/day). The scores will be standardized into z-scores for data analysis based on normative data. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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