A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Tegafur-uracil (UFT)
* Drug: Calcium folinate (LV)
* Drug: Krestin (PSK)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability A (including laparoscopic surgery) (the curability is judged after surgery) Patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (T4) or with histologically positive lymph node metastasis (N+) (to be judged after surgery) Patients who is between 20 and 80 years old at the time of obtaining informed consent Patients with performance status of 0 - 2 Patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation Patients without severe dysfunction of renal, hepatic, or bone marrow function Patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases Patients who have given consent to participate in this clinical study by himself/herself or his/her family Exclusion Criteria: Patients in whom the bottom of tumor reaches the peritoneal reflection Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E) Patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers) Women who are currently pregnant or wish to be pregnant during this clinical study Patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>UFT+LV Group: The group treated with UFT and LV | Drug: Tegafur-uracil (UFT)<br>* 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<br>* Other names: UFT;Drug: Calcium folinate (LV)<br>* From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5<br>* Other names: LV;|
| Experimental: 2<br>UFT+PSK Group: The group treated with of UFT and PSK | Drug: Tegafur-uracil (UFT)<br>* 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<br>* Other names: UFT;Drug: Krestin (PSK)<br>* From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day<br>* Other names: PSK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-Year recurrence-free survival rate |  | 3-years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 5-years after surgery |