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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) studied	Cases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically.
Date of first enrollment	2004/02/01
Target sample size	180
Countries of recruitment	Japan
Study type	Interventional
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 Outcome	Disease-free survival
Secondary Outcome	Overall survival

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude criteria	The patients with other malignant disease, post-operative severe complications, and surgical margin positivity.