NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001560

Registered date:10/12/2008

A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedstage III colorectal cancer
Date of first enrollment2008/03/01
Target sample size140
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)UFT 300mg per m2 per day and LV 75mg per day for 28 days every 5-weeks for 6 months TS-1 80mg per m2 per day for 28 days every 6-weeks for 12 months

Outcome(s)

Primary Outcome3-year disease free survival rate
Secondary Outcomeoverall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1. Severe postoperative complication 2. Serious coexisting illness 1)uncontrolled diabetes mellitus and hypertension 2)history of myocardial infarction, unstable angina within 6 months prior to the registrationsevere 3)pulmonary dysfunction 3. Active diarrhea 4. Multiple cancer 5. Pregnant 6. Disqualified by attending doctor

Related Information

Contact

public contact
Name Hideaki Miyauchi
Address 1-8-1 Inohana, Chu0-ku, Chiba, Japan Japan
Telephone 043-226-2109
E-mail miyahide@faculty.chiba-u.jp
Affiliation Graduate school of medicine Department of frontier surgery
scientific contact
Name Keiji Koda
Address 3426-3 Anegasaki, Ichihara, Japan Japan
Telephone 0436-62-1211
E-mail k-koda@med.teikyo-u.ac.jp
Affiliation Teikyo University Chiba Medical Center Department of surgery