Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer

UMIN ID: C000000245

Registered date:22/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 2005/10/01
• Target sample size: 840
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A (standard therapy group): Administration of 5 courses (6 months) of a schedule (consecutive administration method) in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs.
Group B (trial therapy group): Administration of 15 courses (18 months) of a schedule (5 days on, 2 days off: Saturday and Sunday) in which one course consists of 5 weeks of UFT (300 mg/m2/day) and LV (75 mg/day) for 5 consecutive days followed by 2 days off.

Outcome(s)

• Primary Outcome: disease-free survival
• Secondary Outcome: overall survival, incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female

Include criteria

1) Histologically confirmed colorectal cancer
2) Histological Stage IIB, IIIA, IIIB, IIIC located in colon and rectosigmoid
3) Curative resection with D2 or more lymph node dissection
4) Resection of histological curability A was performed
5) Performance status (ECOG) 0, 1
6) No prior chemotherapy and radiotherapy
7) Oral intake is possible
8) Sufficient organ functions
a) WBC >= 3,000/mm3, <12,000/mm3
b) Neutrophil >=1,500/mm3
c) Hemoglobin >= 9.0g/dL
d) Platelet >= 100,000/mm3
e) Total bilirubin < 1.5mg/dL
f) AST, ALT < 100IU/L
g) Serum creatinine < 1.5mg/dL
9) Chemotherapy will be started within 6 weeks from operation
10) Written informed consent

Exclude criteria

1) active synchronous or metachronous malignancy other than carcinoma in situ
2) 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
3) pregnant or nursing
4) severe mental disorders
5) 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