Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
Conditions
Colorectal Cancer - Liver Metastasis
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Surgery
Type: Procedure
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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.
Location
Kyoto University Hospital
Kyoto, Japan
Status: Recruiting
Contact: Satoshi Nagayama, Assistant - +81-75-751-3227 - nagayama@kuhp.kyoto-u.ac.jp
Start Date
January 2008
Completion Date
May 2013
Sponsors
Kyoto University
Source
Kyoto University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page