Trial · NCT06820957
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to event-free survival (EFS) post-Consolidation I (C1) | From randomization to progression or relapse, diagnosis of a second malignant neoplasm, death, or last patient contact, whichever occurs first, assessed up to 10 years | Analysis will be done by associating each patient's outcome with the individual's randomized treatment assignment. The associated statistical tests will be stratified according to grouping. |
| Secondary | Overall survival-C1 | From randomization to death or last patient contact, whichever occurs first, assessed up to 10 years | The stratified one-sided logrank test will be the primary statistical methodology for assessing the null statistical hypothesis. |
| Secondary | Incidence of adverse events | Up to 30 days after last dose of study treatment | Toxicity will be coded according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. |
| Secondary | Feasibility of augmented dose radiotherapy (ADRT) as local control | Up to point of radiation therapy (RT) termination | The actual RT delivered will be compared with the treatment plan until the point of RT termination as assessed by central review. Will consider ADRT to be feasible to deliver if there is evidence that the patient-specific probability of feasibility-failure is less than 15%. |
| Secondary | Toxicity of ADRT as local control | Up to 30 days after ADRT is completed | Will be evaluated using CTCAE v 5. |
| Secondary | Validation of circulating tumor-derived deoxyribonucleic acid (ctDNA) levels greater than or equal to 5% at the time of diagnosis are associated with increased risk of EFS-event | At time of diagnosis | Will compare the risk for EFS-event from enrollment for groups of patients defined by percent ctDNA at diagnosis using a two-sided logrank test. |
| Secondary | Validation of ctDNA levels greater than or equal to 0.5% following one cycle of chemotherapy are associated with increased risk of EFS-event | Following one cycle of chemotherapy at induction (cycle length = 14 days) | Will compare the risk for EFS-event from enrollment for groups of patients defined by percent ctDNA at induction cycle 1 day 14 using a two-sided logrank test. |
| Other | EFS and response rate for patients with newly diagnosed eligible metastatic round cell sarcomas | At 1 and 2 years | The 95% confidence bounds will be calculated according to the complementary log-log transformation. Will report the 1-, 2- and 3-year estimate EFS probabilities as well as the confidence intervals. |
| Other | Change in fludeoxyglucose F-18 positron emission tomography imaging response of primary disease site and its association with EFS | At the end of 6 cycles of induction chemotherapy (cycle length = 14 days) | Will calculate the percent change in standardized uptake value (SUV). Will fit a Cox proportional hazards regression model for hazard of EFS-event with percent change in SUV included as an independent variable. Nonlinearity will be formally tested using a two degree of freedom Wald test of size 0.05 for the null hypothesis. The functional form of the relationship between hazard of EFS-event and percent change in SUV will be explored by plotting the model-predicted hazard on the logarithmic scale against percent change in SUV with 95% confidence bands. This plot will be examined for natural inflection points in the curve representing potentially informative categories of percent change in SUV. If the p-value for this test is not significant at the 0.05 level, will remove the nonlinear spline terms refitting the model with linear percent change in SUV, and will report the associated hazard ratio and 95% confidence interval. |
| Other | Histologic attributes of Ewing sarcoma and round cell sarcomas that mimic Ewing sarcoma | Up to 10 years | Qualitative characteristics will be quantified with the observed proportion in each category and the associated confidence interval. The sample mean, median, standard deviation, 25th percentile and 75th percentile will be used to characterize the distribution of the quantitative characteristics. |
| Other | ctDNA burden as a continuous variable | Up to following two cycles of chemotherapy (cycle length = 14 days) | Will evaluate differences in hazard of EFS event by ctDNA as a continuous variable modeled as a restricted cubic spline in a proportional hazards regression model. |
| Other | ctDNA burden prior to induction cycle 3 | Following two cycles of chemotherapy (cycle length = 14 days) | Will evaluate whether there is an increased risk of EFS event by ctDNA burden dichotomized at 0.5% prior to induction cycle 3 using a two-sided logrank test. |
| Other | Change in ctDNA burden from diagnosis to local control | Up to following two cycles of chemotherapy (cycle length = 14 days) | Will evaluate differences in hazard of EFS event by change in ctDNA burden as a continuous variable modeled as a restricted cubic spline in a proportional hazards regression model. |
| Other | ctDNA burden after consolidation 1 | Up to 6 months after completion of planned therapy | Will evaluate whether there is an increased risk of EFS event by ctDNA burden dichotomized at 0.5% after consolidation cycle 1 using a two-sided logrank test. |
| Other | Frequency of ctDNA clearance | Through end of consolidation 2 cycle 2 (cycle length = 14 days) | Will describe (proportion and 95% confidence interval overall and stratified by study regimen) the frequency of ctDNA clearance by consolidation 2 cycle 2 among those who have ctDNA burden \> 0.5% at the start of consolidation 2. |
| Other | Frequency of ctDNA-based genetic mutations | At diagnosis | Will describe (proportion and 95% confidence intervals) of genetic mutations detected in ctDNA at diagnosis. |
| Other | Frequency of selected toxicities by Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to 12 months after completion of systemic therapy | Will be evaluated using the PRO-CTCAE. |
| Other | Frequency of selected toxicities by Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) | Up to 12 months after completion of systemic therapy | Will be evaluated using the FACT-G. |
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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