SOAC-1101

JRCT ID: jRCTs031180381

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: high risk stage II/ stage III colorectal cancer
• Date of first enrollment: 23/06/2011
• Target sample size: 200
• Study type: Interventional

Intervention(s)

UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks.
UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks.
Oxaliplatin gives 85 mg/m2 intravenously on 1,15 day of each course.

Outcome(s)

• Primary Outcome: 3-year desiese free survival rate

Secondary Outcome

Overall Survival
Adverse event / Percentage of occurrence of side effects
Percent of administration completed

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Matsubara Hisahiro
• Secondary ID(s): UMIN000007696