Trial · NCT04684368
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Failure rate | Within 2 years of enrollment | Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI). The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity. |
| Primary | Spinal failure rate | Within 2 years of enrollment | Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI. The final analysis will include an exact binomial confidence interval of spinal failure rate. |
| Secondary | Radiographic complete response (CR)/partial response (PR) with marker normalization rate post induction/second-look surgery | Approximately 6 to 9 months post-treatment initiation | Will be assessed in patients treated with induction chemotherapy. Will be estimated using an exact binomial approach and its confidence interval. |
| Secondary | Radiographic complete response (CR)/partial response (PR) with marker normalization rate post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR) | Up to 2 years post-treatment initiation | Will be assessed in patients treated with HDCSCR. Will be estimated using an exact binomial approach and its confidence interval. |
| Secondary | Progression-free survival (PFS) | From enrollment until disease progression or death from any cause for patients with events, and until final follow up for those who are event free at the time of analysis, assessed up to 10 years | Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based PFS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the primary analyses. |
| Secondary | Overall survival (OS) | From enrollment until death from any cause for patients with events and until final follow up for those who are alive at the time of analysis, assessed up to 10 years | Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based OS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the secondary analyses. |
| Secondary | Patterns of disease recurrence/failure | Up to 10 years | Will be analyzed in an exploratory manner with respect to radiation dose distribution. |
| Other | Change in intelligence scores within each treatment arm | Baseline up to 60 months post-treatment initiation | Will be assessed by the Wechsler Preschool and Primary Scale of Intelligence 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children 5th Edition (WISC-V), and the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV), depending on patient's age. One-sample confidence intervals will be used to estimate mean pairwise changes in intelligence scores between 2 time points within each treatment arm. |
| Other | Change in intelligence scores between treatment arms | Baseline up to 60 months post-treatment initiation | Will be assessed by the Wechsler Preschool and Primary Scale of Intelligence 4th Edition (WPPSI- IV), Wechsler Intelligence Scale for Children 5th Edition (WISC V), and the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV), depending on patient's age. A 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies. |
| Other | Change in processing speed/attention within each treatment arm | Baseline up to 60 months post-treatment initiation | Will be assessed by the WISC-V or WAIS-IV processing speed index tasks. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within each treatment arm. |
| Other | Change in processing speed/attention between the two treatment arms | Baseline up to 60 months post-treatment initiation | Will be assessed by the WISC-V or WAIS-IV processing speed index tasks. A 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies. |
| Other | Change in immediate visual memory within each arm | Baseline up to 60 months post-treatment initiation | Will be assessed by the Children's Memory Scale and California Verbal Learning Test. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate. |
| Other | Change in social-emotional functioning within each arm | Baseline up to 60 months post-treatment initiation | Will be assessed by the Behavior Assessment System for Children - 3rd Edition. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate. |
| Other | Change in adaptive functioning within each arm | Baseline up to 60 months post-treatment initiation | Will be assessed by the Adaptive Behavior Assessment System - 3rd Edition. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate. |
| Other | Change in health-related quality of life within each arm | Baseline up to 60 months post-treatment initiation | Will be assessed by the Pediatric Quality of Life Inventory version 4.0. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate. |
| Other | Change in health-related quality of life between the two treatment arms | Baseline up to 60 months post-treatment initiation | Will be assessed by the Pediatric Quality of Life Inventory version 4.0. 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies. |
| Other | Radiation modality (proton versus photon) | Up to 10 years | Will summarize and compare functional outcomes, including cognitive, social and behavioral functioning, and auditory and neuro-endocrine function, in the context of the radiation therapy modality used. Two sample t-tests for specified timepoints within each of the two treatment cohorts (WVSCI versus HDCSCR) will be used for comparisons. |
| Other | Growth comparisons following radiation by radiation modality | Up to 10 years | Will compare early and late outcomes for proton and photon therapy with and without vertebral body sparing. Height and weight of subjects who are \< 13 years at the time of radiation therapy will be collected until subjects go off study or reach the age of 21, whichever is earlier. Percentile values standardizing height and weight based on appropriate growth curves will be used to compare cohorts treated with proton- versus photon-based radiation therapy. |
| Other | Complete blood count values following radiation by radiation modality | Up to 1 year post treatment initiation | Complete blood count values during radiation therapy will be used to compare these outcomes in the context of proton- versus photon-based radiation therapy. |
| Other | Local versus central review recommendations for second-look surgery | Up to 1 year post treatment initiation | Will summarize the local versus central review recommendations for second-look surgery and document any discrepancies. |
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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