NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000013

Registered date:01/07/2005

A randomized controlled trial by a parallel group design in multi-institutions to evaluate the effectiveness of oral adjuvant chemotherapy using Leucovorin and Tegaful/Uracil to prevent recurrence after resection of liver metastasis from colorectal carcinoma.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedCases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically.
Date of first enrollment2004/02/01
Target sample size180
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Oral administration of Leucovorin (75mg/day) and Tegaful/Uracil (300mg/body surface area m2/day) for 5 courses (5 weeks of administration followed by 1 week of no administration) after curative resection of liver metastasis from colorectal carcinoma. Only follow-up without any anti-cancer therapy after curative resection of liver metastasis from colorectal carcinoma.

Outcome(s)

Primary OutcomeDisease-free survival
Secondary OutcomeOverall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteriaThe patients with other malignant disease, post-operative severe complications, and surgical margin positivity.

Related Information

Contact

public contact
Name Norihiro Kokudo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411(33320)
E-mail KOKUDO-2SU@h.u-tokyo.ac.jp
Affiliation Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division
scientific contact
Name Norihiro Kokudo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411(33320)
E-mail KOKUDO-2SU@h.u-tokyo.ac.jp
Affiliation Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division