Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497107
Status:
UNKNOWN
Last Update Posted:
2008-07-31
First Post:
2007-07-05
Brief Title:
Uracil and TegafurLeucovorin UFTLV Versus UFTLV Polysaccharide-K PSK for Stage IIIaIIIb Colorectal Cancer
Sponsor:
Iwate Medical University
Organization:
Iwate Medical University
Study Overview
Official Title:
Phase III Randomized Controlled Clinical Study of UFTLV Therapy Versus UFTLV PSK Therapy as Postoperative Adjuvant Therapy for Histological Stage IIIa and IIIb Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2008-07
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:
ICOG
Brief Summary:
The purpose of this study is to conduct a randomised controlled trial RCT comparing UFTLV and UFTLV PSK in patients with histological stage IIIaIIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival DFS as the primary endpoint and also to analyze the 3-year overall survival OS compliance adverse events quality of life QOL and relationship with tumor factors
Detailed Description:
To conduct a randomized controlled trial comparing chemotherapy using UFTLV and immunochemotherapy using UFTLV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer adenocarcinoma who have undergone curative surgery without residual cancer R0 using 3-year disease-free survival rate as primary endpoint and also to analyze the 3-year overall survival compliance adverse events QOL and relationship with tumor factors
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