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

Phase 3
20 Years
75 Years
Open (Enrolling)
Colorectal Neoplasms

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Trial Information

Randomized Phase III 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:

1. Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma,
or signet-ring cell carcinoma).

2. Tumor is mainly located in between cecum and upper rectum, excluding that invades to
lower rectum.

3. 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(-).

4. No synchronous colorectal cancer which invade muscularis propria or deeper.

5. Tumor resection with D2 or D3 lymph node dissection was performed.

6. Pathological determination of curability of tumor resection is cur A.

7. Age at registration is above 20 and below 75 years old.

8. ECOG Performance status is 0 or 1.

9. No prior chemotherapy or radiation therapy.

10. Intake of normal diet and oral drugs is possible.

11. 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

12. Adjuvant chemotherapy can be started within 9 weeks after surgery.

13. Written informed consent is taken.

Exclusion Criteria:

1. Active co-existing malignancy (synchronous or metachronous malignancy whose disease
free period is within 5 years). Carcinoma in situ is eligible.

2. Severe postoperative complications which do not resolve until registration.

3. 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

4. Pregnant or breast-feeding woman.

5. Difficult to participate with the trial, having mental disorder or psychiatric

6. Judged to be inappropriate to register.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

during the study conduct

Safety Issue:


Principal Investigator

Yoshihiro Moriya, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 2003

Completion Date:

November 2011

Related Keywords:

  • Colorectal Neoplasms
  • adjuvant chemotherapy
  • Stage III colorectal cancer
  • 5-FU+l-LV
  • UFT+LV
  • randomized controlled trial
  • Neoplasms
  • Colorectal Neoplasms