Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments uft, usel/leucovorin, krestin
Phase phase 3
Sponsor Hokkaido Gastrointestinal Cancer Study Group
Collaborator Hokkaido University Hospital
Start date April 2005
End date December 2012
Trial size 340 participants
Trial identifier NCT00209742, HGCSG-CAD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
uft tegafur-uracil
P.O. everyday
usel/leucovorin Leucovorin
P.O. everyday
(Experimental)
uft tegafur-uracil
P.O. everyday
usel/leucovorin Leucovorin
P.O. everyday
krestin PSK
P.O. everyday
(Active Comparator)
uft tegafur-uracil
P.O. everyday
usel/leucovorin Leucovorin
P.O. everyday

Primary Outcomes

Measure
3-years disease-free survival rate (DFS)
time frame: 5-years

Secondary Outcomes

Measure
Dose intensity (compliance), 5-year disease-free survival rate, 3- and 5-year survival rate, incidence of other adverse drug reactions, QOL
time frame: 7-years

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: 1. Patients with primary colonic carcinoma or rectal carcinoma of histological stage III, who have undergone histological curability A or B surgeries 2. Patients evaluated histologically as lymph node metastasis positive 3. Patients aged between 20 and 80 years, inclusive, at the time of acquisition of informed consent 4. Patients with performance status 0 to 2 5. Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy) 6. Gastrointestinal function: Patients with no diarrhea (watery stool) 7. Patients without severe impairment of renal, hepatic and bone marrow functions 8. Patients with no serious concurrent complications (such as infection) 9. Patients who have given written informed consent to participate in this study Exclusion Criteria: 1. Patients graded as curability C 2. Patients with stenosis not capable of oral intake 3. Among disease stage IIIa cases, those that are si/n(-) and ai/n(-) 4. Patients with fresh hemorrhage from the gastrointestinal tract 5. Patients with retention of body fluid necessitating treatment 6. Patients with infection, intestinal palsy or intestinal occlusion 7. Patients with the lower end of the tumor involving the peritoneal reflection 8. Patients with lower rectal cancer (Rb), involving the anal canal (P) or perianal skin (E) 9. 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) 10. Patients who are pregnant or hope to become pregnant during the study period 11. Patients with poorly controlled diabetes or are treated by continuous use of insulin 12. Patients with a history of ischemic heart disease 13. Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study 14. Patients receiving continuous administration of steroids 15. Patients who have experienced serious drug allergy in the past 16. Others, patients judged by the investigator or subinvestigator to be inappropriate as subject

Additional Information

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
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Hokkaido Gastrointestinal Cancer Study Group.