Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

NCT ID: NCT00209742

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2012-12-31

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).

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Group Type: EXPERIMENTAL

UFT

Intervention Type: DRUG

P.O. everyday

USEL/Leucovorin

Intervention Type: DRUG

P.O. everyday

3

Group Type: EXPERIMENTAL

UFT

Intervention Type: DRUG

P.O. everyday

USEL/Leucovorin

Intervention Type: DRUG

P.O. everyday

Krestin

Intervention Type: DRUG

P.O. everyday

1

Group Type: ACTIVE_COMPARATOR

UFT

Intervention Type: DRUG

P.O. everyday

USEL/Leucovorin

Intervention Type: DRUG

P.O. everyday

Interventions

UFT

P.O. everyday

Intervention Type: DRUG

USEL/Leucovorin

P.O. everyday

Intervention Type: DRUG

Krestin

P.O. everyday

Intervention Type: DRUG

Other Intervention Names

tegafur-uracil; Leucovorin; PSK

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hokkaido University Hospital

OTHER

Sponsor Role: collaborator

Hokkaido Gastrointestinal Cancer Study Group

OTHER

Sponsor Role: lead

Responsible Party

Hokkaido Gastrointestina Cancer Study Group

Principal Investigators

Masahiro Asaka, MD, PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Sapporo, Hokkaido, Japan

Countries

Japan

Other Identifiers

HGCSG-CAD

Identifier Type: -

Identifier Source: org_study_id