Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer

Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer - Randomized Phase II Study of Antineoplastons as an Adjuvant Therapy for Liver Metastases from Colorectal Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012099

Enrollment

Registered

2013-10-22

Start date

1998-04-01

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 Metastases from Colorectal Cancer

Interventions

In both the AN arm and the control arm, patients received HAI with 5-FU at a dose of 1000 mg/m2 for 4 hours weekly or biweekly until the cumulative dose reached up to 15,000 mg. In the AN arm, a start

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients had histologically confirmed metastatic colorectal adenocarcinoma to the liver. Patients were treated with R0 resection of liver metastases and/or complete ablation by radio frequency interstitial ablation therapy between April 1998 and August 2004 at Kurume University Hospital. The inclusion criteria were age <75 years, no severe major organ dysfunction, no prior cancer therapy to the liver, no extra-hepatic metastases at study entry, Eastern Cooperative Oncology Group (ECOG) performance status 2, no other malignancy (within the 5 years prior to study entry), white blood cell count >=3000/&micro;L, absolute neutrophil count >=1500/&micro;L, platelet count >=75,000/&micro;L, total bilirubin <2.0 mg/Dl and serum creatinine <2.0. Computed tomography (CT) scans of the chest, abdomen, and pelvis were required to have been carried out within the 6 weeks prior to protocol registration. All patients provided signed informed consent after hepatectomy

Exclusion criteria

Exclusion criteria: 1)No treatment with chemotherapeutics and radiation 2)Simultaneous or metachronous double cancers 3)Pregnant or lactating women or women of childbearing potential 4)Other patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
The primary objective was to determine whether systemic administration of antineoplastons added to adjuvant 5-FU HAI after liver resection increased cause-specific survival (CSS).	—

Secondary

Measure	Time frame
Secondary endpoints were evaluation of relapse-free survival (RFS), grade of recurrence and toxicity.	—

Countries

Japan

Contacts

Public ContactYutaka Ogata

Kurume University Medical Center Department of Surgery

yogata@med.kurume-u.ac.jp0921-22-6111

Outcome results

None listed

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