Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
A randomized controlled study is conducted on patients with histological stage III colorectal cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin (UFT+LV), UFT+LV / UFT, or UFT+LV+PSK / UFT+PSK. The usefulness of the three regimens was evaluated by comparing the disease-free survival rate, overall survival rate, incidence and severity of adverse event, and quality of life.

Detailed Description
-----------------
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).

Official Title
-----------------
Randomized Phase III Clinical Study Comparing Postoperative UFT+LV, UFT+LV/UFT and UFT+LV+PSK/UFT+PSK Therapies for Stage III Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: UFT
* Drug: USEL/Leucovorin
* Drug: Krestin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary colonic carcinoma or rectal carcinoma of histological stage III, who have undergone histological curability A or B surgeries Patients evaluated histologically as lymph node metastasis positive Patients aged between 20 and 80 years, inclusive, at the time of acquisition of informed consent Patients with performance status 0 to 2 Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy) Gastrointestinal function: Patients with no diarrhea (watery stool) Patients without severe impairment of renal, hepatic and bone marrow functions Patients with no serious concurrent complications (such as infection) Patients who have given written informed consent to participate in this study Exclusion Criteria: Patients graded as curability C Patients with stenosis not capable of oral intake Among disease stage IIIa cases, those that are si/n(-) and ai/n(-) Patients with fresh hemorrhage from the gastrointestinal tract Patients with retention of body fluid necessitating treatment Patients with infection, intestinal palsy or intestinal occlusion Patients with the lower end of the tumor involving the peritoneal reflection Patients with lower rectal cancer (Rb), involving the anal canal (P) or perianal skin (E) Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) Patients who are pregnant or hope to become pregnant during the study period Patients with poorly controlled diabetes or are treated by continuous use of insulin Patients with a history of ischemic heart disease Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study Patients receiving continuous administration of steroids Patients who have experienced serious drug allergy in the past Others, patients judged by the investigator or subinvestigator to be inappropriate as subject

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br> | Drug: UFT<br>* P.O. everyday<br>* Other names: tegafur-uracil;Drug: USEL/Leucovorin<br>* P.O. everyday<br>* Other names: Leucovorin;|
| Experimental: 3<br> | Drug: UFT<br>* P.O. everyday<br>* Other names: tegafur-uracil;Drug: USEL/Leucovorin<br>* P.O. everyday<br>* Other names: Leucovorin;Drug: Krestin<br>* P.O. everyday<br>* Other names: PSK;|
| Active Comparator: 1<br> | Drug: UFT<br>* P.O. everyday<br>* Other names: tegafur-uracil;Drug: USEL/Leucovorin<br>* P.O. everyday<br>* Other names: Leucovorin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years disease-free survival rate (DFS) |  | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose intensity (compliance), 5-year disease-free survival rate, 3- and 5-year survival rate, incidence of other adverse drug reactions, QOL |  | 7-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer,UFT,LV,Krestin,adjuvant therapy,phase III