Ignite Creation Date:
2024-05-06 @ 12:56 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03880877
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2019-03-17
Brief Title:
Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated in Patients With Previously Treated Metastatic Colorectal Cancer
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated According to UGT1A1 Genotyping Versus Regorafenib Monotherapy in Patients With Previously Treated Metastatic Colorectal Cancer A Prospective Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
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:
A prospective multicenter randomized in a 21 ratio controlled clinical trial with two parallel arms will be conducted to compare irinotecan dose escalated FOLFIRI according to UGT1A1 genotyping plus 120 mg regorafenib with 120 mg regorafenib alone in previously treated patients with metastatic colorectal cancer mCRC
Detailed Description:
Primary objective
Progression-free survival
Secondary objective
Overall survival best objective response disease control rate time to progression duration of treatment and adverse events
Number of Subjects 153 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting
Plan of the Study
1 This is a prospective multicenter randomized in a 21 ratio controlled study
2 Study Schedule Study date the time getting approval letter issued by both regulatory authority and institutional review board IRB Duration of the study 4 years
3 Duration of Treatment Treatment was administered until disease progressed
Progression-free survival
Secondary objective
Overall survival best objective response disease control rate time to progression duration of treatment and adverse events
Number of Subjects 153 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting
Plan of the Study
1 This is a prospective multicenter randomized in a 21 ratio controlled study
2 Study Schedule Study date the time getting approval letter issued by both regulatory authority and institutional review board IRB Duration of the study 4 years
3 Duration of Treatment Treatment was administered until disease progressed
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?:
None
Is an FDA AA801 Violation?:
None