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

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00594529
• Other study ID #: C-206
• Secondary ID: UMIN000000961
• Status: Recruiting
• Phase: Phase 2
• First received: January 4, 2008
• Last updated: June 22, 2011
• Start date: January 2008
• Est. completion date: May 2013

Study information

• Verified date: August 2009
• Source: Kyoto University
• Contact: Satoshi Nagayama, Assistant
• Phone: +81-75-751-3227
• Email: nagayama[@]kuhp.kyoto-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: May 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Surgery
Liver resection for metastatic liver lesions

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Curative resection rates of liver metastases		2 years after the operations	Yes
Secondary	Completion rates of neoadjuvant chemotherapy		2 years after the operation	Yes