Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: UFT; Drug: USEL/Leucovorin; Drug: Krestin

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).

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8638
      • ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hokkaido Gastrointestinal Cancer Study Group
• Collaborators: Hokkaido University Hospital
• Investigators: Study Chair: Masahiro Asaka, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): May 26, 2010
• Last Update Submitted That Met QC Criteria: May 24, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Colorectal Cancer,UFT,LV,Krestin,adjuvant therapy,phase III
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Protective Agents; Micronutrients; Adjuvants, Immunologic; Antibiotics, Antineoplastic; Vitamins; Antidotes; Vitamin B Complex; Interferon Inducers; Radiation-Protective Agents; Leucovorin; Levoleucovorin; Tegafur; polysaccharide-K
• Other Study ID Numbers: HGCSG-CAD