Trial · NCT03971409
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 | Best Overall Response Rate (BORR) | From treatment initiation until disease progression, an estimated average of 1 year | BORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and will be reported for each arm along with 95% two-sided confidence intervals. |
| Secondary | Overall Response Rate (ORR) | From treatment initiation until disease progression, an estimated average of 1 year | ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) assessed by Immune-Related RECIST (iRECIST) and will be reported by arm with 95% two-sided confidence intervals |
| Secondary | Clinical Benefit Rate (CBR) | 6 months | CBR is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) using RECIST version 1.1 at 6 months and will be reported by arm with 95% two-sided confidence intervals |
| Secondary | Median Progression-free Survival (PFS) | From treatment initiation until disease progression, an estimated average of 1 year | The median duration of progression-free survival in weeks by arm will be estimated using the Kaplan-Meier method with censoring used as needed. Median time to event and corresponding confidence intervals will be reported. |
| Secondary | Median Overall Survival (OS) | 12 months | OS is defined as the time from treatment initiation until disease progression or death, whichever comes first and will be reported by arm with 95% two-sided confidence intervals . |
| Secondary | Percentage of participants with treatment-related adverse events | Up to 30 days after completion of study treatment, approximately 13 months | An unacceptable toxicity is defined as any unexpected and clinically relevant drug-related grade 3 toxicity, or any drug-related grade 4-5 adverse event within the first cycle of therapy assessed via National Cancer Institute CTCAE version 5 criteria. Safety will be evaluated by estimating the percentage of patients who experience a clinically relevant toxicity (both patient and physician reported) for each arm with 95% two-sided confidence intervals. |
| Secondary | Change in Quality of Life at 8 Weeks Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Measure | Baseline up to 8 weeks | Will be measured the PROMIS Global Short Form. Change scores will be compared across treatment arms using one way analysis of variance (ANOVA) with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn's adjustment for multiple comparisons. |
| Secondary | Change in Quality of Life Over Treatment Duration Assessed by PROMIS Global Health Measure | From baseline until the date disease progression is first observed, an estimated average of 1 year | Will be measured the PROMIS Global Short Form. Change scores will be compared across treatment arms using one way analysis of variance (ANOVA) with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn's adjustment for multiple comparisons. |
| Secondary | Change in Symptoms (Self-Reported Toxicities) at 8 Weeks Assessed by Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline up to 8 weeks | Will be measured by the PRO-CTCAE criteria . The data will be presented descriptively using summary statistics and graphical representations across time points. Will assess symptom burden using Likert scores. Each attribute will be presented descriptively using summary statistics and graphical representations across time points. |
| Secondary | Change in Symptoms (Self-Reported Toxicities) Over Treatment Duration Assessed by PRO-CTCAE | From baseline until the date disease progression is first observed, an estimated average of 1 year | Will be measured by the PRO-CTCAE criteria . The data will be presented descriptively using summary statistics and graphical representations across time points. Will assess symptom burden using Likert scores. Each attribute will be presented descriptively using summary statistics and graphical representations across time points. |
| Secondary | Change in Ability to Participate in Social Roles and Activities at 8 Weeks Assessed by PROMIS | Baseline up to 8 weeks | The data will be presented descriptively using summary statistics and graphical representations across time points. Change scores will be compared across treatment arms using one way ANOVA with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn?s adjustment for multiple comparisons. |
| Secondary | Change in Ability to Participate in Social Roles and Activities Over Treatment Duration Assessed by PROMIS | From baseline until the date disease progression is first observed, an estimated average of 1 year | The data will be presented descriptively using summary statistics and graphical representations across time points. Change scores will be compared across treatment arms using one way ANOVA with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn?s adjustment for multiple comparisons. |
| Secondary | Change in Treatment Satisfaction at 8 Weeks Assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM) | Baseline up to 8 weeks | Will be assessed by TSQM Questionnaire. Change scores will be compared across treatment arms using one way ANOVA with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn?s adjustment for multiple comparisons. |
| Secondary | Change in Treatment Satisfaction Over Treatment Duration Assessed by the TSQM | From baseline until the date disease progression is first observed, an estimated average of 1 year | Will be assessed by TSQM Questionnaire. Change scores will be compared across treatment arms using one way ANOVA with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn?s adjustment for multiple comparisons. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03971409/registered