A Phase III Study of Intra-Arterial Hepatic Chemotherapy with 5-FU (WHF) in Patients with Liver Metastases from Colorectal Carcinoma

A Phase III Study of Intra-Arterial Hepatic Chemotherapy with 5-FU (WHF) in Patients with Liver Metastases from Colorectal Carcinoma - A Potential Adjuvant Study of Intra-Arterial Hepatic Chemotherapy with 5-FU in Combination with Systemic Chemotherapy (UFT/oral LV) vs Systemic Chemotherapy alone (JFMC32-0501)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000075

Enrollment

280

Registered

2005-08-25

Start date

2005-02-01

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

Liver excision

Interventions

Hepatic arterial infusion of 5-FU 1000mg/m2 once a week for 6 months, followed by UFT 300mg/m2/day and leucovorin 75mg/day until 1 year after surgery UFT 300mg/m2/day and leucovorin 75mg/day until 1 y

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Curatively resected metastatic liver tumors form colorectal cancer 2) The first time hepatic resection 3) Potentially curative resection of hepatic metastases without current evidence of other metastatic disease 4) No evidence of carcinoma on the cut surface of hepatic resection 5) No extrahepatic sites of disease 6) No prior chemotherapy and radiotherapy to the liver 7) If adjuvant chemotherapy after primary colorectal tumor resection was used, at least 3 months since prior chemotherapy 8) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions (1) WBC >= 3,000/mm3 (2) Platelet >= 100,000/mm3 (3) Hemoglobin >= 9.0g/dL (4) Total bilirubin <= 1.5mg/dL (5) AST < 100IU/L (6) ALT < 100IU/L (7) Protronbin time >=50% (8) Serum creatinine <= 1.5mg/dL (9) BUN <= 25mg/dL (10) Total protein >= 5.9g/dL (11) Albumin >= 3.0g/dL (12) CRP <= 2.1mg/dL 9) Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1 10) Oral intake is possible 11) 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; diabetes mellitus, uncontrolled or controlled with insulin b; uncontrolled hypertension c; history of myocardial infarction, unstable angina within 6 months prior to the registration d; liver cirrhosis e; severe pulmonary dysfunction 4) pregnant or nursing 5) severe mental disorders 6) not suitable for participating in the study for any other reason

Design outcomes

Primary

Measure	Time frame
disease free survival	—

Secondary

Measure	Time frame
survival, recurrence in residual liver, recurrence in extrahepatic lesion, adverse events	—

Countries

Japan

Outcome results

None listed

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