Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495463
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-27
Brief Title:
Lonsurf TrifluridineTipiracil Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
The Efficacy of Lonsurf TrifluridineTipiracil Plus Chemotherapy in Metastatic Colorectal Cancer Multi-center Prospective Study in Taiwan
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Endpoint To evaluate the Disease control rate DCR
Secondary Endpoints
To evaluate the Progression-free survival PFS Overall survivalOS and Safety profile
Secondary Endpoints
To evaluate the Progression-free survival PFS Overall survivalOS and Safety profile
Detailed Description:
70 Per-protocol patients Plan to recruit 70 evaluable patients With expected dropout rate of 22 the sample size would be 90 subjects Simons two-stage design Simon 1989 will be used The null hypothesis that the true response rate is 045 will be tested against a one-sided alternative In the first stage 42 patients will be accrued If there are 19 or fewer responses in these 42 patients the study will be stopped Otherwise 28 additional patients will be accrued for a total of 70 The null hypothesis will be rejected if 39 or more responses are observed in 70 patients This design yields a type I error rate of 005 and power of 08 when the true response rate is 06
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None