Trial · NCT02699073
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 | Tumor response rate at 2 months according Choi Criteria | 2 months after the beginning of treatment | |
| Secondary | Tumor response rate at 1 and 2 months according to RECIST1.1 | At 1 month and 2 months after the beginning of treatment | |
| Secondary | Tumor response rate at 1 month according to Choi criteria | At 1 month after the beginning of treatment | |
| Secondary | Best overall response rate (BOR) according to Choi criteria and to RECIST 1.1 | BOR is the best response recorded from the strat of treatment until treatment failure up to 36 months | |
| Secondary | Disease control rate (DCR) | DCR is the proportion of patient with tumor response (CR or RP) or tumor stabilization as best response from the inclusion until treatment failure, up to 36 months | |
| Secondary | Overall Survival (OS) | Assessed from the date of study drug start to the date of patient death, due to any cause or to the last date the patient was known to be alive, up to 36 months | |
| Secondary | Progression free survival (PFS) | PFS is the time from the date of study drug start to the date of progressive disease or death due to any cause, up to 36 months | |
| Secondary | Specificity of Choi criteria at 1 month in identifying patients with long or short OS (using median OS as cut-off value). | At 1 month after inclusion | |
| Secondary | Evaluation of tumor heterogeneity with TexRAD software | At baseline and 1 month after inclusion | Threshold of the CTTA parameters (Skewness, Kurtosis, Entropy, Uniformity) provided by the TexRAD software at baseline and optimal variations of these parameters on the CT performed at one month (compared to baseline). |
| Secondary | Serious adverse events( SAE) and adverse event (AE) | Up to 36 months | assessed by NCI-CTCAE4.0 |
| Secondary | Identify early prognostic biomarkers of regorafenib | at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment | |
| Secondary | Correlation between Baseline cell free DNA and survival outcomes (PFS and OS) | at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment |
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
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GET https://conductscience.org/api/trials/v1/NCT02699073/registered