NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001367

Registered date:10/09/2008

An Open-Label Randomized Phase III Study of Capecitabine(6 months) versus Capecitabine(12 months) as Adjuvant Chemotherapy for Stage III(Dukes'C) Colon Cancer Patients.

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedColon cancer
Date of first enrollment2008/09/01
Target sample size1200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Capecitabine (Xeloda) is administered orally as tablets, 1250 mg/m2 twice 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 (6 months). Capecitabine (Xeloda) is administered orally as tablets, 1250 mg/m2 twice daily for 14 -days followed by a 7-days resting period without treatment, as an intermittent therapy in a 3-weeks cycle for 16 treatment cycles (12 months).

Outcome(s)

Primary OutcomeDisease free survival
Secondary OutcomeRelapse free survival, Overall survival, 2-year disease-free survival rate, Adverse events, Individual dose intensity, Health related quality of life, Pharmacoeconomics

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 cancer 3) Curative resection with D2 or more lymph node dissection 4) Resection of histological curability A was performed 5) Performance status(ECOG): 0 or 1 6) No prior chemotherapy and radiotherapy 7) Oral intake is possible 8) Sufficient organ functions WBC >= 3,000/mm3, <12,000/mm3 Hemoglobin >= 9.0g/dL Platelet >= 90,000/mm3 Serum creatinine <= 1.5xULN Total bilirubin <= 1.5 xULN AST,ALT <= 2.5xULN ALP <= 2.5xULN 9) Creatinine clearance >50mL/min 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 Japanese Foundation for Multidisciplinary Treatment of Cancer
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
E-mail jfmc-dc@jfmc.or.jp
Affiliation Japanese Foundation for Multidisciplinary Treatment of Cancer Office
scientific contact
Name Naohiro Tomita
Address 1-1, Mukogawa , Nishinomiya City, Hyogo, 663-8501, Japan Japan
Telephone
E-mail
Affiliation Hyogo College of Medicine Department of Surgery