Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma

Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma - Randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004029

Enrollment

Registered

2010-09-01

Start date

2010-09-01

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

Oxaliplatin(130mgm-2) was administered as a 2-h infusion every 3 weeks. Patients received S-1 orally twice daily from the evening of day 1 to the morning of day 15 at a dose of 40 mg (BSA&lt

1.25m2), 50 mg (&amp

#8805

1.25, &lt

1.50m2), or 60mg (&amp

1.50m2) followed by a 7-day rest period in the 3-weekly schedule. Oxaliplatin(100mgm-2) was administered as a 2-h infusion every 3 weeks. Patients received S-1 orally twice daily from the evening o

1.50m2) followed by a 7-day rest period in the 3-weekly schedule.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing first 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
Discontinuation rate associated with toxicity	—

Secondary

Measure	Time frame
Relapse-free survival Disease-free survival Toxicity	—

Countries

Japan

Contacts

Public ContactMitsuyoshi Ota

Yokohama City University Graduate School of Medicine Gastroenterological surgery

m_ota@yokohama-cu.ac.jp045-787-2650

Outcome results

None listed

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