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Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis

Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis - Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021146
Enrollment
18
Registered
2016-02-22
Start date
2016-02-15
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

Liver resection for liver metastasis of colorectal cancer

Interventions

Oral administration of Tegaful/Uracil 200-300mg/m2/day and leucovorin 75mg/day for 5 course (5 weeks of administration followed by 1 week of no administration)

Sponsors

Oita university, faculty of medicine, department gastroenterology and pediatric surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically proven colorectal cancer 2.Case with liver metastasis simultaneously or metachronously 3.No extrahepatic sites of disease 4.Curatively resected metastatic liver tumor 5.Performance status must be Eastern Cooperative Oncology Group (ECOG) 0 or 1 6.Oral intake is possible 7.Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 8.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Active synchronous or metachronous malignancy other than carcinoma in situ 2.Serious postoperative complications 3.Serious coexisting illness A) Uncontrolled diabetes mellitus B) Uncontrolled hypertension C) History of myocardial infarction, unstable angina within 6 months prior to the registration D) Severe pulmonary dysfunction E) Liver cirrhosis 4.Ascites or pleural effusion needed to 5.Positive HBs antigen 6.Bleeding, paralysis, obstruction or ulcer of gastrointestinal tract 7.Pregnant or nursing 8.Severe mental disorders 9.Not suitable for participating in the study for any other Reason by the physician

Design outcomes

Primary

MeasureTime frame
Optimal dose

Secondary

MeasureTime frame
Adverse event, Overall survival, Disease free survival, Pharmacokinetics

Countries

Japan

Contacts

Public ContactYukio Iwashita

Oita university faculty of medicine Gastroenterological and pediatric surgery

iwashita@oita-u.ac.jp097-586-5843

Outcome results

None listed

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