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Preoperative Hepatic Arterial Infusion Chemotherapy

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ClinicalTrials.gov Identifier: NCT00522509
Recruitment Status : Unknown
Verified May 2007 by IRCCS San Raffaele.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2007
Last Update Posted : August 29, 2007
Sponsor:
Information provided by:
IRCCS San Raffaele

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

Condition or disease Intervention/treatment
Colorectal Liver Metastases Drug: Floxuridine FUDR

Detailed 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.


Study Type : Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Preoperative Hepatic Arterial Infusion Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases
Study Start Date : December 1995

Resource links provided by the National Library of Medicine

Drug Information available for: Floxuridine





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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable liver metastases
  • Potentially resectable liver metastases

Exclusion Criteria:

  • Extrahepatic disease

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 ClinicalTrials.gov identifier (NCT number): NCT00522509


Locations
Italy
Department of Surgery - Liver Unit, Scientific Institute San Raffaele,
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Luca Aldrighetti, M.D, PhD Department of Surgery - Liver Unit, Scientific Institute San Raffaele,

ClinicalTrials.gov Identifier: NCT00522509     History of Changes
Other Study ID Numbers: Neoadjuvant HAIC
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Floxuridine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents