Trial · NCT04166409
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival (EFS) | Up to 10 years from date of randomization | The Kaplan-Meier method will be used to estimate EFS which is defined as the interval from randomization to first occurrence of clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, or to the date of last follow-up. Estimates with 95% confidence intervals will be reported by treatment arm. The hazard ratio with a confidence interval will also be reported to compare treatment arms based on a Cox proportional hazards model stratified by BRAF status, tumor location and size of residual tumor. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome. |
| Secondary | Radiographic tumor response rate | Up to 10 years | Percentages of patients with responses (complete or partial response) will be reported by treatment arm with 95% confidence intervals. The result of an exact binomial test to test for the difference in response rates between treatment arm will also be reported. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome. |
| Secondary | Overall survival (OS) | Up to 10 years from date of randomization | The Kaplan-Meier method will be used to estimate OS by treatment arm, defined as the interval from randomization to death from any cause, or to the date of last follow-up. Estimates with confidence intervals will be reported by treatment arm. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome. |
| Secondary | Number of patients who experience an improvement in visual acuity (VA) | After the first 12 months of treatment | Numbers of patients that show improvement in VA after 12 months of treatment will be reported by treatment arm. Patients with at least 1 impaired eye are evaluable. In a patient with a unilateral optic nerve glioma, only the affected eye is considered. In patients with bilateral visual impairment, if VA improves in 1 eye but worsens in the other, the patient will be coded as a treatment failure, whereas if 1 eye improves and the other is at least stable, the patient will be coded as a success. |
| Secondary | Change in motor function | After 48 weeks of therapy | Motor function is measured using the Vineland-3 Motor Scale. Only patients with motor function deficits at baseline are included. Magnitudes of change from baseline between the 2 treatment arms and provide a 90% 2-sided confidence interval for this difference. |
| Secondary | Change in quality of life (QOL) | Baseline and 9 months after treatment initiation | QOL will be measured using the PedsQL Total Scale Score as measured from the validated PedsQL Generic Module (for children 2-21 years old). Mean differences in the total scale score between 9 months and baseline will be reported by treatment arm. The results of 2-sample t-test comparing differences in the QOL scores between the 2 arms will also be reported. If change scores do not follow normal distributions, non-parametric alternatives may be employed for analysis. |
| Secondary | Processing speed function | Up to 9 months post-treatment initiation | Measured by Wechsler Processing Speed Index (standard score). Scores at 9 months will be summarized by treatment arm and reported as means (with standard deviations) or medians (with ranges) depending on the data distribution. |
| Secondary | Change in executive function | Baseline and 9-months | Executive function will be measured by the Behavior Rating Inventory of Executive Function, Second Edition BRIEF Cognitive Regulation Index (CRI). Summary statistics for the differences in scores from baseline to 9 months will be reported by treatment arm. |
| Other | Change in QOL scores over time | At baseline, 9 months, 30 months, and 60 months after treatment initiation | QOL scores for each domain of the PedsQL Generic module will be summarized by timepoint (4 timepoints) and treatment arm. Mean QOL scores will be reported with standard deviations. If scores do not follow normal distributions, medians and ranges will be reported instead. |
| Other | Change in neurocognitive functioning scores over time | At baseline, 9 months, 30 months, and 60 months after treatment initiation | Neurocognitive functioning scores for each index/scale of the Behavior Rating Inventory of Executive Function, Second Edition/Preschool Version/Adult will be summarized by timepoint (4 timepoints) and treatment arm. Mean scores will be reported with standard deviations. If scores do not follow normal distributions, medians and ranges will be reported instead. |
| Other | EFS by sex | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex. |
| Other | EFS by race | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race. |
| Other | EFS by ethnicity | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity. |
| Other | OS by sex | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex. |
| Other | OS by race | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race. |
| Other | OS by ethnicity | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity. |
| Other | Neurocognitive outcomes by sex | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex. |
| Other | Neurocognitive outcomes by race | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race. |
| Other | Neurocognitive outcomes by ethnicity | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity. |
| Other | QOL by sex | Up to 10 years from date of randomization | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04166409/registered