Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00209742
• Other study ID #: HGCSG-CAD
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 24, 2010
• Start date: April 2005
• Est. completion date: December 2012

Study information

• Verified date: May 2010
• Source: Hokkaido Gastrointestinal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 340
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• UFT
P.O. everyday
• USEL/Leucovorin
P.O. everyday
• Krestin
P.O. everyday

Locations

Country	Name	City	State
Japan	· Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)	Sapporo	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Hokkaido Gastrointestinal Cancer Study Group	Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-years disease-free survival rate (DFS)		5-years	Yes
Secondary	Dose intensity (compliance), 5-year disease-free survival rate, 3- and 5-year survival rate, incidence of other adverse drug reactions, QOL		7-years	Yes