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NCT00522509 Clinical Trial

Preoperative Hepatic Arterial Infusion Chemotherapy

Colorectal Liver Metastases Clinical Trial

Official title:
Preoperative Hepatic Arterial Infusion Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00522509
Other study ID # Neoadjuvant HAIC
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 28, 2007
Last updated August 28, 2007
Start date December 1995

Study information
Verified date May 2007
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Istituto Superiore di Sanità
Study type Observational

Clinical Trial Summary

To assess the feasibility and results of liver resection after preoperative hepatic artery infusion (HAI) chemotherapy with FUDR.

Description:

Between 1995 and 2004, 239 patients with isolated colorectal liver metastases received HAI chemotherapy with neoadjuvant intent. Fifty of these patients underwent subsequent curative liver resection (HAI group).

Postoperative morbidity, liver function tests, and long term outcomes were evaluated. Adverse events related to HAI chemotherapy were also evaluated.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Unresectable liver metastases

- Potentially resectable liver metastases

Exclusion Criteria:

- Extrahepatic disease

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Drug:
• Floxuridine FUDR

Locations
Country Name City State
Italy Department of Surgery - Liver Unit, Scientific Institute San Raffaele, Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

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