Trial · NCT06998940
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From date of randomization to date of death due to any cause, assessed up to 3 years | Analysis of OS will be conducted in all eligible participants according to the intent-to-treat principle using a 1-sided stratified log rank test. |
| Secondary | Objective response rate (ORR) | Up to 3 years after randomization | Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be compared across treatment arms via Fisher's exact test. |
| Secondary | Disease control rate | Up to 3 years after randomization | Will be compared across treatment arms via Fisher's exact test. |
| Secondary | Duration of response (DoR) | Up to 3 years after randomization | The distributions of DoR will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test. |
| Secondary | Progression free survival (PFS) | From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years | The distributions of PFS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test. |
| Secondary | Incidence of adverse events | Up to 30 days after last study treatment | |
| Secondary | OS in participants with MAPK negative cancers | From date of randomization to date of death due to any cause, assessed up to 3 years | The distributions of OS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test. |
| Secondary | PFS in participants with MAPK negative cancers | From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years | The distributions of PFS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test. |
| Secondary | ORR in participants with MAPK negative cancers | Up to 3 years after randomization | Will be compared across treatment arms via Fisher's exact test. |
| Other | Health-related quality of life (QOL) | At 8 weeks after randomization | Measured by the Functional Assessment of Cancer Therapy - General (FACT-G) total score. Analysis will be conducted using multiple linear regression analysis, adjusting for the clinical study-specified stratification factors (which are also anticipated to influence QOL endpoints), and the baseline score as covariates. |
| Other | Impact of treatment toxicity | At 8 weeks after randomization | Measured by the Functional Assessment of Chronic Illness Therapy Item GP5 (FACIT Item GP5). Analysis will be conducted using multiple linear regression analysis, adjusting for the clinical study-specified stratification factors, and the baseline score as covariates. |
| Other | Changes in health related QOL | Baseline up to 24 weeks after randomization | Will be assessed using FACT-G total score. Linear regression models will be used for longitudinal modeling, with robust errors estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. Covariates for longitudinal modeling will include intervention assignment, the assessment timepoint, the baseline score, and the stratification factors. The potential for differential dropout by arm will be mitigated by reminder notifications to site investigators to encourage proper assessment and submission of forms at every required time point for all participants. Cohort plots will be prepared to examine the extent to which missing data are informative (i.e., scores are higher (worse) for participants just before their data are missing for the subsequent assessment). If there is evidence of non-random dropout, pattern-mixture models will be utilized as a sensitivity analysis. |
| Other | Change in impact of treatment toxicity | Baseline up to 24 weeks post randomization | Will be assessed using FACIT Item GP5. Linear regression models will be used for longitudinal modeling, with robust errors estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. Covariates for longitudinal modeling will include intervention assignment, the assessment timepoint, the baseline score, and the stratification factors. The potential for differential dropout by arm will be mitigated by reminder notifications to site investigators to encourage proper assessment and submission of forms at every required time point for all participants. Cohort plots will be prepared to examine the extent to which missing data are informative (i.e., scores are higher (worse) for participants just before their data are missing for the subsequent assessment). If there is evidence of non-random dropout, pattern-mixture models will be utilized as a sensitivity analysis. |
| Other | Patient reported symptoms | Up to 30 days after last study treatment | Patient-reported symptoms will be assessed by treatment arm using selected patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items including gastrointestinal, dermatologic as well as constitutional symptoms of pain and fatigue. For each of the PRO-CTCAE adverse events examined, the scores for each attribute (frequency, severity and/or interference) will be presented descriptively using summary statistics at each assessment time. Additionally, the worst severity and/or interference over the entire course will be summarized. |
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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