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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594529
Recruitment Status : Unknown
Verified August 2009 by Kyoto University.
Recruitment status was:  Recruiting
First Posted : January 15, 2008
Last Update Posted : June 23, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastasis Procedure: Surgery Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : May 2010
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
1 Procedure: Surgery
Liver resection for metastatic liver lesions

Primary Outcome Measures :
  1. Curative resection rates of liver metastases [ Time Frame: 2 years after the operations ]

Secondary Outcome Measures :
  1. Completion rates of neoadjuvant chemotherapy [ Time Frame: 2 years after the operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594529

Contact: Satoshi Nagayama, Assistant +81-75-751-3227

Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Satoshi Nagayama, Assistant    +81-75-751-3227   
Sponsors and Collaborators
Kyoto University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dept. Surgery, Kyoto Univ. Identifier: NCT00594529     History of Changes
Other Study ID Numbers: C-206
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: August 2009

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases