Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01917552
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2013-07-30
Brief Title:
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric CancerKCSG ST14-05 CATALYSIS
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB by AJCC 6th Edition Gastric CancerKCSG ST14-05
Status:
RECRUITING
Status Verified Date:
2024-02
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:
multi-center prospective randomized open-label phase III
Detailed Description:
This is a prospective randomized open-label phase III study of adjuvant chemotherapy after curative resection in patients with pathologic stage IB by AJCC 6th edition gastric cancer with at least one additional risk factor additional risk factors for recurrence include age 65 years male gender presence of lymphovascular invasion presence of perineural invasion The superiority design will compare the efficacy and safety profiles of adjuvant capecitabine Arm A versus observation alone Arm B
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