Randomized Phase III Clinical Study Comparing Postoperative UFT+LV, UFT+LV/UFT and UFT+LV+PSK/UFT+PSK Therapies for Stage III Colorectal Cancer
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 (UFT+LV) (5 courses), UFT+LV (5 courses) / UFT (1 year), or
UFT+LV+PSK (5 courses) / UFT+PSK (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).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3-years disease-free survival rate (DFS)
5-years
Yes
Masahiro Asaka, MD, PhD
Study Chair
Hokkaido Gastrointestinal Cancer Study Group
Japan: Ministry of Health, Labor and Welfare
HGCSG-CAD
NCT00209742
April 2005
December 2012
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