Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216034
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2005-09-18
Brief Title:
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1PSK
Sponsor:
Hokuriku-Kinki Immunochemotherapy Study Group
Organization:
Hokuriku-Kinki Immunochemotherapy Study Group
Study Overview
Official Title:
Randomized Multicenter Controlled Phase III Study of Postoperative Adjuvant Therapy for Stage IIIIIA Gastric Cancer Using TS-1 Alone or TS-1PSK Combined Therapy
Status:
COMPLETED
Status Verified Date:
2016-06
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:
A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1 with the objective to examine or validate the outcome QOL and prognostic factors host and tumor factors and explore the factors enhancing the antitumor effect of TS-1
Detailed Description:
The 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II IIIA IIIB and IV Tegafur-gimeracil-oteracil potassium TS-1 is used as the first line treatment for advanced and recurrent gastric cancer But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer the beneficial results of survival rates using Krestin PSK in combination with chemotherapy have been reported With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None