A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]

A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study] - A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013324

Enrollment

Registered

2014-03-04

Start date

2014-02-07

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

Surgical hepatectomy followed by chemotherapy (XELOX)8cycles. &lt

XELOX&gt

(L-OHP 130 mg/m2 day1 , Capecitabine 2,000mg/m2/day day1-14)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histlogically proven colorectal carcinoma. (2)Curatively resected metastatic liver tumors of colorectal cancer. (3)No extrahepatic metastatis. (4)No history of thermocoagulation therapy and cryotherapy for livermetastasis. (5)Within 42-70 days from the date of liver resection. (6)Age >= 20 years. (7)Performance status(ECOG) of 0-1. (8)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions. (9)Cases that meet all the following criteria (Check all items using the test values of the latest within 14 days prior to entry). 1. Neutrophil count >=1500/mm3 2. Hemoglobin >=8.0g/dL (That you have not done a blood transfusion within 14 days prior to entry). 3. Platelets>=100,000/mm3 4. Total bilirubin <=2.0g/dL 5. AST <=100IU/L 6. AST <=100IU/L 7. Creatinine<=1.5mg/dL (10)Written informed consent.

Exclusion criteria

Exclusion criteria: (1) Synchronous multiple malignancy (2)Previously treated L-OHP. (3) More than 180days after the last chemotherapy. (4)Pregnant or nursing. (5) Severe peripheral neuropathy. (6) History of severe anaphylaxis or allergia (7)Active infection (8)Severe mental disorder. (9) Severe comorbidity. (10)Systemic steroid user. (11)Patients under treatment with flucytosine,phenytoin,warfarin potassium. (12)Hepatitis B virus infection. (13)Watery diarrhea. (14)Consider not appropriate for the study.

Design outcomes

Primary

Measure	Time frame
3-year Disease-Free Survival	—

Secondary

Measure	Time frame
Overall Survival relative dose intensity Adverse events	—

Countries

Japan

Contacts

Public ContactNaotoshi Sugimoto

Osaka International Cancer Institute Department of Medical Oncology

sugimoto-na2@mc.pref.osaka.jp06-6945-1181

Outcome results

None listed

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