Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-07 @ 8:54 PM
Study NCT ID:
NCT03130634
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2017-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2020-05
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 objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Detailed Description:
Primary Objective:
Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Patient Selection and Enrollment:
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Plan of the Study:
Study Design This is an open-label, randomized, comparative, double arm, single center study to assess efficacy of Silymarin as adjuvant therapy on metastatic colorectal cancer patients undergoing FOLFIRI chemotherapy in Taiwan.
Subject Number Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Duration of study: From the date of the IRB was approved till the 70th patient was collected.
Duration of Enrollment: From the date of the IRB was approved till the 70th patient was collected.
Duration of treatment: From the 1st patient starting chemotherapy till the 70th patient finishing the 6th cycle chemotherapy.
Duration of follow-up: From the 1st patient starting chemotherapy till 3 months after the 70th patient finishing the 6th cycle chemotherapy
Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Patient Selection and Enrollment:
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Plan of the Study:
Study Design This is an open-label, randomized, comparative, double arm, single center study to assess efficacy of Silymarin as adjuvant therapy on metastatic colorectal cancer patients undergoing FOLFIRI chemotherapy in Taiwan.
Subject Number Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Duration of study: From the date of the IRB was approved till the 70th patient was collected.
Duration of Enrollment: From the date of the IRB was approved till the 70th patient was collected.
Duration of treatment: From the 1st patient starting chemotherapy till the 70th patient finishing the 6th cycle chemotherapy.
Duration of follow-up: From the 1st patient starting chemotherapy till 3 months after the 70th patient finishing the 6th cycle chemotherapy
Study Oversight
Has Oversight DMC:
True
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?: