Feasibility study of Capecitabine as adjuvant chemotherapy for stage III colon cancer including RS cancer.

UMIN ID: UMIN000001444

Registered date:22/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: stage III colon cancer including RS cancer
• Date of first enrollment: 2008/07/16
• Target sample size: 92
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Capecitabine is administrated orally as tablets, 2,500 mg/m2 daily for 14 days followed by a 7-days resting period without treatment, as an intermittent therapy in a 3-weeks cycle for 8 treatment cycles.

Outcome(s)

• Primary Outcome: the rate of completion of treatment as planned
• Secondary Outcome: Safety Cumulative incidence of Hand-foot syndrome and hepatic dysfunction 3-years disease free survival rate 5-years disease free survival rate 3-years overall survival rate 5-years overall survival rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Pregnant or nursing 2)Medical history of allergy or hypersensitivity reactions to fluoropyrimidines 3)The past of the internal organ transplant 4)Serious coexisting illness a;severe pulmonary dysfunction b;ileus or colon dysfunction c;uncontrolled diabetes mellitus d;liver cirrhosis e;uncontrolled hypertension f;history of myocardial infarction, unstable angina within 6 months prior to the registration 5)Active synchronous or metachronous malignancy other than carcinoma in situ 6)Uncontrollable infectious disease 7)Not suitable for participating in the study for any other reason

Related Information

• Primary Sponsor: KSCC
• Source(s) of Monetary Support: CReS Kyushu