SOAC-1101

Phase 2

• Conditions: high risk stage II/ stage III colorectal cancer; Colorectal Cancer

• Registration Number: JPRN-jRCTs031180381
• Lead Sponsor: Matsubara Hisahiro

Brief Summary

Registered from 18 facilities from April 2010 to April 2015. A study was conducted on 159 patients with colorectal cancer who underwent curative resection of high-risk Stage II and Stage III, of which 154 had a safety analysis and 151 had a 3-year disease-free survival comparison. 76 patients were assigned to the UFT / LV group and 75 patients were assigned to the TEGAFOX group. The 3-year disease-free survival was 84.2% (95% confidence interval; 73.9-90.7): 62.1 (95% confidence interval; 50.0-72.1) in the

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2020-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

1) Confirmed adenocarcinoma
2) High risk stage II or stage III colorectal cancer
3) Recieved curative resction
4) 20 years old or older
5) PS(ECOG) 0 or 1
6) No previous treatment exclude surgery
7) Oral intake is possible
8) Adequate organ fanction
9) Treatment can start within eight weeks after surgery.
10) Written informed consent

Exclusion Criteria

1) Serious diarrea
2) Serious postoperative complications
3) Serious drug hypersensitivity
4) Pregnant or nursing
5) Serious coexisting illness
1; diabetes mellitus, uncontrolled or controlled with insulin
2; uncontrolled hypertension
3; liver cirrhosis
4; renal disfaunction
5; severe pulmonary dysfunction
6; active infection
7; history of myocardial infarction, unstable angina within 6 months prior to the registration
6) Active synchronous or metachronous malignancy other than carcinoma in situ
7) Sensory neuropathy
8) Severe mental disorders
9) Not suitable for participating in the study for any other reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year desiese free survival rate

Secondary Outcome Measures

Name	Time	Method
Overall Survival<br>Adverse event / Percentage of occurrence of side effects<br>Percent of administration completed