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 colorectal cancer 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
Osaka University Hospital
Suita, Osaka, Japan
3-Year recurrence-free survival rate
Time frame: 3-years after surgery
5-Year survival rate, incidence of adverse events, treatment compliance, QOL, type of metastasis/recurrence, and 3-year and 5-year recurrence-free survival rates and survival rates based on each parameter including colon/rectum, stage, and IAP.
Time frame: 5-years after surgery
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