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.

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. - A randomized controlled trial for adjuvant LV+UFT therapy after resection of liver metastasis from colorectal carcinoma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000013

Enrollment

180

Registered

2005-07-01

Start date

2004-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically.

Interventions

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 resect

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing first or second resection for liver metastasis from colorectal carcinoma. No residual disease after surgery and no disease except for liver metastasis and the primary colorectal carcinoma.

Exclusion criteria

Exclusion criteria: The patients with other malignant disease, post-operative severe complications, and surgical margin positivity.

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactNorihiro Kokudo

Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division

KOKUDO-2SU@h.u-tokyo.ac.jp03-3815-5411(33320)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026