NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000193

Registered date:12/09/2005

Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedStage III colorectal cancer
Date of first enrollment2003/02/01
Target sample size1100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: 5FU+l-leucovorin B: UFT+Leucovorin

Outcome(s)

Primary OutcomeDisease-free survival
Secondary OutcomeOverall survival, Rate of adverse event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1) 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) Witten informed consent is taken.
Exclude criteria1) Active co-existing malignancy (synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible. 2) Severe postoperative complicatoins which do not resolve until registration. 3) There is following complicaion. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pactoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema 4) Pregnant or breast-feeding woman. 5) Difficult to participate with the trial, having mentel disorder or psychiatric symptoms. 6) Judged to be inappropriate to register.

Related Information

Contact

public contact
Name Yasuhiro Shimada, MD
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045 Japan
Telephone
E-mail JCOG_sir@ml.jcog.jp
Affiliation JCOG0205 Coordinating Office Division of medical oncology, National Cancer Center Hospital
scientific contact
Name Yasuhiro Shimada, MD
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045 Japan
Telephone
E-mail
Affiliation National Cancer Center Hospital Division of medical oncology