A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV)
administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with
pTNM stage IIB or III (UICC Sixth version) colorectal cancer/histological curability A
(Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a
multicenter collaborative randomized open-label comparative controlled study and
consequently to determine the usefulness of the above regimens as adjuvant therapy after
surgery.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3-Year recurrence-free survival rate
3-years after surgery
No
Morito Monden, MD, PhD
Study Chair
Multicenter Clinical Study Group of Osaka
Japan: Ministry of Health, Labor and Welfare
MCSGO-CCTG-0501
NCT00385970
March 2006
April 2015
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