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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Kyoto University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kyoto University
ClinicalTrials.gov Identifier:
NCT00594529
First received: January 4, 2008
Last updated: June 22, 2011
Last verified: August 2009
  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
Liver Metastasis
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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: May 2013
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Dept. Surgery, Kyoto Univ.
ClinicalTrials.gov Identifier: NCT00594529     History of Changes
Other Study ID Numbers: C-206, UMIN000000961
Study First Received: January 4, 2008
Last Updated: June 22, 2011
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014