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

Phase 2

• Conditions: Colorectal Cancer; Liver Metastasis
• Interventions: Procedure: Surgery

• Registration Number: NCT00594529
• Lead Sponsor: Kyoto University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Status Verified: 2009-08
• Primary Completion: 2010-05
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Surgery	-

Primary Outcome Measures

Name	Time	Method
Curative resection rates of liver metastases	2 years after the operations

Secondary Outcome Measures

Name	Time	Method
Completion rates of neoadjuvant chemotherapy	2 years after the operation

Trial Locations

Locations (1)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan