A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.

UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.

5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.

Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

Inclusion criteria

• Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
• Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
• Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
• No synchronous colorectal cancer which invade muscularis propria or deeper.
• Tumor resection with D2 or D3 lymph node dissection was performed.
• Pathological determination of curability of tumor resection is cur A.
• Age at registration is above 20 and below 75 years old.
• ECOG Performance status is 0 or 1.
• No prior chemotherapy or radiation therapy.
• Intake of normal diet and oral drugs is possible.
• Major organ function is preserved. WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl
• Adjuvant chemotherapy can be started within 9 weeks after surgery.
• Written informed consent is taken.

Exclusion criteria

• Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
• Severe postoperative complications which do not resolve until registration.
• There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
• Pregnant or breast-feeding woman.
• Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
• Judged to be inappropriate to register.