Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT03517618
Brief Summary:
Primary Objective:
To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated metastatic colorectal cancer
Secondary Objectives:
* To determine objective response rate (ORR)
* To determine time to progression (TTP)
* To determine overall survival (OS)
* To assess incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\]
Detailed Description:
Simon's optimal two-stage design will be used to determine the sample size for this study.
• Stage I: \>1/9: The first 9 evaluable patients enrolled, \>1 (or ≥2) responders are required in order to enter the second stage, otherwise the trial will be terminated at the first stage due to futility.
• Stage II: Total \>8/34: For the total 34 evaluable patients, \>8 (or ≥9) responders are required to conclude the effectiveness of the study regimen.
The primary endpoint will be disease control rate which will be presented in frequency tabulation with two-sided 95% confidence interval (using binomial estimation).
The secondary endpoints are described as follows:
* ORR will be presented in frequency tabulation with two-sided 95% confidence interval;
* TTP will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
* OS will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
* Incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\] : assessed by CTCAE v4.0. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.
Study:
NCT03517618
Study Brief:
Protocol Section:
NCT03517618