Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Feasibility Study of Neoadjuvant Chemotherapy mFOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
This study is currently recruiting participants.
Verified by Kyoto University, December 2007
Sponsored by: Kyoto University
Information provided by: Kyoto University
ClinicalTrials.gov Identifier: NCT00594529
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Metastatic Liver Lesions
Procedure: Surgery
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Further study details as provided by Kyoto University:

Primary Outcome Measures:
  • Curative resection rates of liver metastases [ Time Frame: 2 years after the operations ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Completion rates of neoadjuvant chemotherapy [ Time Frame: 2 years after the operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: January 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Surgery
Liver resection for metastatic liver lesions

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594529

Contacts
Contact: Satoshi Nagayama, Assistant +81-75-751-3227 nagayama@kuhp.kyoto-u.ac.jp

Locations
Japan
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Satoshi Nagayama, Assistant     +81-75-751-3227     nagayama@kuhp.kyoto-u.ac.jp    
Sponsors and Collaborators
Kyoto University
  More Information

Responsible Party: Dept. Surgery, Kyoto Univ. ( Dept. Surgery, Kyoto Univ. )
Study ID Numbers: C-206, UMIN000000961
Study First Received: January 4, 2008
Last Updated: February 14, 2008
ClinicalTrials.gov Identifier: NCT00594529  
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University:
Neoadjuvant chemotherapy
Metastatic liver lesions from colorectal cancers

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009