Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00594529

Enrollment

Registered

2008-01-15

Start date

2008-01-31

Completion date

2013-05-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Metastasis

Keywords

Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers

Brief summary

The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.

Interventions

PROCEDURESurgery

Liver resection for metastatic liver lesions

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers. 2. Liver lesions are measurable by spiral CT or SPIO-MRI scans. 3. Extrahepatic lesions include lung metastases which can be resected curatively. 4. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved. 5. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA 6. No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection 7. Performance status (ECOG): 0-1 8. Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.

Exclusion criteria

Excluded are cases with conditions as below: 1. Peritoneal or pleural fluid retention to be drained. 2. Multiple malignancies to be treated. 3. Peripheral neural disturbances. 4. Active infectious diseases. 5. Severe watery diarrhea. 6. Mental disturbances. 7. Treatment history of continuous, oral or intravenous steroid therapy. 8. Previous history of ischemic heart diseases. 9. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure. 10. Pregnant. 11. Previous history of severe drug-induced allergy.

Design outcomes

Primary

Measure	Time frame
Curative resection rates of liver metastases	2 years after the operations

Secondary

Measure	Time frame
Completion rates of neoadjuvant chemotherapy	2 years after the operation

Countries

Japan

Contacts

Primary ContactSatoshi Nagayama, Assistant

nagayama@kuhp.kyoto-u.ac.jp+81-75-751-3227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026