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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03130634
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
Study:
NCT03130634
Study Brief:
Protocol Section:
NCT03130634