I Phase Surgery vs Staged Surgery for Synchronous Liver Metastasis of Colorectal Cancer - A Prospective, Randomized, Control Trial - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00677586

Purpose

To investigate the safety of simultaneous liver resections compared to staged hepatectomies of colorectal cancer with liver metastasis and to compare the long-term survival between the two groups.

Condition	Intervention	Phase
Colorectal Neoplasms	Procedure: simultaneous resection of liver metastasis and the colorectal primary tumor Procedure: staged resection of liver metastasis and the colorectal primary tumor	Phase IV

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Fudan University:

Primary Outcome Measures:

post-operative complication, peri-operative mortality [ Time Frame: 90 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

5 years survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	January 2000
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental simultaneous resection of liver metastasis and the colorectal primary tumor	Procedure: simultaneous resection of liver metastasis and the colorectal primary tumor simultaneous resection of liver metastasis and the colorectal primary tumor
2: Active Comparator staged resection of the liver metastasis and the colorectal primary tumor	Procedure: staged resection of liver metastasis and the colorectal primary tumor Patients received resection of the colorectal tumor. 1 months later received resection of liver metastasis

Detailed Description:

A consecutive patients of colorectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age <= 60 years
resectable primary colorectal tumor
remnant liver volume >= 70%
without other organ metastasis or peritoneum metastasis
without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

age > 60 years
unresectable primary colorectal tumor
remnant liver volume < 70%
with other organ metastasis or peritoneum metastasis
with contradiction of cardiac and pulmonary diseases

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	zhongshan hospital, fudan university ( xu jianmin )
Study ID Numbers:	20080507
Study First Received:	May 12, 2008
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00677586
Health Authority:	China: Ministry of Health

Keywords provided by Fudan University:

colorectal neoplasms
liver metastasis
surgery

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 14, 2009