Trial · NCT03844620
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC) | First 4 months after treatment initiation | Number of patients with rise in ctDNA level will be compared to Number of patients with progression of disease on scans. |
| Primary | Treatment-related adverse events (TRAEs) of interest (grade 3/4 toxicity, intolerable grade 2 toxicity, or any toxicity requiring dose reduction) between arms | First 4 months after treatment initiation | Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. To compare the proportions of patients who have experienced TRAEs of interest within the first 4 months between the two treatment arms, Fisher's exact test will be used. |
| Secondary | Mean patient-reported outcomes (PROs) score as per MD Anderson Symptom Inventory (MDASI-GI) | Up to 18 months | Mean PROs scores measured by MDASI-GI scales will be compared between arms |
| Secondary | Mean patient-reported outcomes (PROs) score as per PRO-CTCAE | Up to 18 months | Mean PROs scores measured by PRO-CTCAE scales will be compared between arms |
| Secondary | Percentage of patients with partial response (PR) | Up to 18 months | Percentage of patients with PR will be compared between arms |
| Secondary | Percentage of patients with stable disease (SD) | Up to 18 months | Percentage of patients with SD will be compared between arms |
| Secondary | Overall survival (OS) | Up to 18 months | OS will be compared between arms. |
| Secondary | Percentage of patients who present with events of special interest (ESIs) | Up to 18 months | Percentage of patients who present with ESIs \[described as either Hospitalizations/emergency room visits or need for medical interventions (blood transfusions and IV hydration)\] will be compared between arms |
| Secondary | Cost measured in US dollars | Up to 18 months | Cost measured in US dollars will be compared between arms |
| Secondary | Median time to performance status deterioration | Up to 18 months | Will be compared between arms. |
| Secondary | Median time to PRO deterioration | Up to 18 months | Will be compared between arms. |
| Secondary | Proportion of patients referred to clinical trial | Up to 18 months | Will be compared in both arms. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03844620/registered