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.

UMIN ID: UMIN000001367

Registered date:10/09/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Colon cancer
• Date of first enrollment: 2008/09/01
• Target sample size: 1200
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: Disease free survival
• Secondary Outcome: Relapse 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 minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female

Include criteria

1) 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 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: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer