Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209742
Status:
UNKNOWN
Last Update Posted:
2010-05-26
First Post:
2005-09-12
Brief Title:
Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Organization:
Hokkaido Gastrointestinal Cancer Study Group
Study Overview
Official Title:
Randomized Phase III Clinical Study Comparing Postoperative UFTLV UFTLVUFT and UFTLVPSKUFTPSK Therapies for Stage III Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
ACTIVE_NOT_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 randomized controlled study is conducted on patients with histological stage III colorectal cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin UFTLV UFTLV UFT or UFTLVPSK UFTPSK The usefulness of the three regimens was evaluated by comparing the disease-free survival rate overall survival rate incidence and severity of adverse event and quality of life
Detailed Description:
A multicenter randomized open-label controlled study is conducted on patients with histological stage III and curability A or B colorectal cancer according to General Rules for Clinical and Pathological Studies on Cancer of the Colon Rectum and Anus 6th edition Japanese Classification of Colorectal Cancer English edition also according to pTNM classification to facilitate overseas publication given postoperative oral therapy of tegafur-uracil plus leucovorin UFTLV 5 courses UFTLV 5 courses UFT 1 year or UFTLVPSK 5 courses UFTPSK 1 year The usefulness of the three regimens as postoperative adjuvant therapy was evaluated by comparing the disease-free survival rate DFR overall survival rate OS incidence and severity of adverse event and quality of life QOL
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