NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001444

Registered date:22/10/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedstage III colon cancer including RS cancer
Date of first enrollment2008/07/16
Target sample size92
Countries of recruitmentJapan
Study typeInterventional
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 Outcomethe rate of completion of treatment as planned
Secondary OutcomeSafety 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria1)Histologically confirmed Colorectal adenocarcinoma 2)Histological Stage III Colon,Rectosigmoid 3)Curative resection with D2 or more lymph node dissection 4)Resection of histological curability A was performed 5)age:20-80years old 6)Performance status(ECOG):0or1 7)No prior chemotherapy and radiotherapy 8)Oral intake is possible 9)Sufficient organ functions 10)Chemotherapy will be started within 8 weeks from operation 11)Written informed consent
Exclude criteria1)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

Contact

public contact
Name KSCC
Address Maidashi 3-1-1,Higashi-ku,Fukuoka,812-8582 Japan
Telephone 092-631-2920
E-mail kscc2@cres-kyushu.or.jp
Affiliation CReS Kyushu KSCC
scientific contact
Name Maehara Yoshihiko
Address Maidashi 3-1-1,Higashi-ku,Fukuoka,812-8582 Japan
Telephone 092-631-2920
E-mail kscc2@cres-kyushu.or.jp
Affiliation Kyushu University Dpt. of surgery and science