Trial · NCT07466316
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 | Event free survival (EFS) | From randomization until the first occurrence of progression or relapse, second malignancy, or death, assessed up to 5 years | Will be estimated using the Kaplan-Meier method and will be compared between the randomized treatment groups using the stratified log-rank test. |
| Secondary | Overall survival (OS) | From randomization to death from any cause, assessed up to 4 years | Will be estimated using the Kaplan-Meier method and will be compared between the randomized treatment groups using the stratified log-rank test. |
| Secondary | Clinician-reported adverse events (AEs) | Up to 5 years | Clinician-reported treatment-related grade 3 or higher AEs will be reported using Common Terminology Criteria for Adverse Events version 5.0. Comparison of toxicities will be conducted using Fisher's exact test. The maximum grade for each toxicity will be recorded for each patient. Averages and confidence intervals for these toxicity frequencies will be provided. |
| Secondary | Proportion of patients undergoing delayed primary excision (DPE) among patients deemed to be DPE eligible on retrospective central review | Up to week 12 of treatment | Eligibility for DPE will be established through a retrospective central review of diagnostic and pre-local control imaging. Among the patients deemed eligible for DPE, the proportion of those who undergo DPE will be determined along with 95% confidence interval. Cohen's kappa will be used to assess the concordance between site reviews and central reviews. 95% confidence of kappa statistics will be provided. |
| Secondary | Local failure rate for patients deemed eligible for DPE | Up to 5 years | Cumulative incidence curves will be used to present the local failure rates over time. |
| Secondary | Percentage of molecular biomarker testing that is resulted within the 6-week timeframe | Up to cycle 3 (each cycle is 21 days) | Assessing the feasibility of reporting diagnostic tumor molecular features in patients with clinical group III intermediate risk rhabdomyosarcoma via the molecular characterization initiative (MCI) among the first 50 Clinical Group III patients who initiated treatment and consent to MCI. If 14 or more patients cannot have diagnostic tumor molecular features identified via MCI within 6 weeks of treatment, this aim will be considered not feasible. |
| Other | Somatic molecular features TP53 mutation | Up to 5 years | Binary (1 = Mutation present, 0 = Mutation absent) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test |
| Other | Somatic molecular features MYCN amplification | Up to 5 years | Binary (1 = Amplified, 0 = Not amplified) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test. |
| Other | Somatic molecular features MYOD1 mutation | Up to 5 years | Binary (1 = Mutation present, 0 = Mutation absent) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test. |
| Other | Somatic molecular features CDK4 amplification | Up to 5 years | Binary (1 = Not amplified, 0 = Amplified) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test. |
| Other | Methylation patterns: EFS | Up to 5 years | Deoxyribonucleic acid (DNA) methylation data from rhabdomyosarcoma tumors collected during the conduct of ARST2531 will be analyzed. This data will be collected by array-based methods as part of MCI. The clinical significance of the rhabdomyosarcoma subsets determined in our DNA methylation studies will be analyzed. The association of DNA methylation subsets to EFS will be analyzed using the log-rank test and Cox model. |
| Other | Methylation patterns: OS | Up to 5 years | DNA methylation data from rhabdomyosarcoma tumors collected during the conduct of ARST2531 will be analyzed. This data will be collected by array-based methods as part of MCI. The clinical significance of the rhabdomyosarcoma subsets determined in our DNA methylation studies will be analyzed. The association of DNA methylation subsets to OS will be analyzed using the log-rank test and Cox model. |
| Other | Use of digital pathology/artificial intelligence: Risk predictions compared to EFS | 4 years from study enrollment | Risk predictions will be recorded and ultimately compared to clinical outcomes, specifically 4-year EFS. |
| Other | Use of digital pathology/artificial intelligence: Risk predictions compared to OS | 4 years from study enrollment | Risk predictions will be recorded and ultimately compared to clinical outcomes, specifically 4-year OS. |
| Other | Clinical practices of fertility discussions/procedures | Up to 5 years | Fertility consultation information (risk assessment, available fertility preservation options) will be collected and summarized using frequency and percentage. Frequency and percentage of eligible patients undergoing fertility preservation procedures will be summarized. |
| Other | Patient derived xenograft rhabdomyosarcoma model generation | Pre-treatment and cycle 3 (each cycle is 21 days) | Will viably collect tumor samples for generation of patient-derived xenograft models that can be used in future research studies to advance the understanding of rhabdomyosarcoma biology. |
| Other | Household material hardship (HMH) | At time of survey completion, from enrollment until start of cycle 3 (each cycle is 21 days) | HMH will be analyzed first as a binary variable (present/absent) and then as an ordinal (0-4) variable. Cox proportional hazard model will be used to assess the association between the binary HMH variable with EFS and OS. Then association between the ordinal measure and EFS and OS will be assessed using COX model. |
| Other | EFS by treatment arm within racial subgroups | Up to 5 years | Will be estimated using the Kaplan-Meier method. The corresponding 95% confidence interval (CI) will be estimated using Peto-peto method. |
| Other | EFS by treatment arm within ethnicity subgroups | Up to 5 years | Will be estimated using the Kaplan-Meier method. The corresponding 95% CI will be estimated using Peto-peto method. |
| Other | EFS by treatment arm within sex subgroups | Up to 5 years | Will be estimated using the Kaplan-Meier method. The corresponding 95% CI will be estimated using Peto-peto method. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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