A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer

A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer - A phase II study of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000996

Enrollment

Registered

2008-01-25

Start date

2006-07-01

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 of colorectal cancer

Interventions

To undergo modified folfox 6 regimen [5-fluorouracil 2.4 g/m2 (24-h continuous infusion), l-leucovorin 200 mg/m2 (2-h intravenous infusion), and oxaliplatin 85 mg/m2 (2-h intravenous infusion) every 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) First treatment for metastatic liver tumors of colorectal cancer (2) Histologically confirmed metastatic liver tumors of colorectal cancer (3) R0 and R1 after resection of both primary and metastatic tumors (4) No extrahepatic tumors (5) Performance status is 0-2 (6) Function of main organs is kept as below. WBC is from lower normal limit to 12,000/mm3. Neutrophil is over 1,500/mm3. Platet is over 100,000/mm3. Hb is over 9.0/dL. Total bilirubin is within 1.5 times of normal limits. AST and ALT are within 2.5 times of normal limits. ALP is within 2.5 times of normal limits. Creatinin is within normal limits. (7) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Multiple cancer (2) Prebious history of severe drug-induced allergy (3) Given L-OHP within 6 months before this study (4) Active infection (5) Severe complication (6) Severe sensory disturbance (7) Pregnant (8) Disqualified by attendig doctor

Design outcomes

Primary

Measure	Time frame
disease free survival side effect	—

Secondary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactKuniharu Yamamoto

Miyagi HBPCOG coordinating office Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine.

kyama@surg1.med.tohoku.ac.jp022-717-7208

Outcome results

None listed

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