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Treatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis

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ClinicalTrials.gov Identifier: NCT00273247
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : January 9, 2006
Sponsor:
Collaborator:
Associazione Italiana per la Ricerca sul Cancro
Information provided by:
National Cancer Institute, Milan

Brief Summary:
We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of HCC(control group)

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatitis C Virus Infection Liver Cirrhosis Interferon Treatment Hepatic Resection Drug: Interferon alpha-2b Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant α-Interferon Treatment After Resection of Hepatocellular Carcinoma in HCV-Related Cirrhosis: a Randomized Trial on Prevention of Cancer Recurrence
Study Start Date : June 1998
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Recurrence Free Survival

Secondary Outcome Measures :
  1. Disease Specific Survival
  2. Overall Patient Survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV-RNA positive / HBsAg-negative patients with HCC undergoing potentially curative resection
  • Curative surgery (i.e. no residual tumor intraoperative US and tumor-free margins at pathology)
  • No recurrence 1 month after surgery (CT, NMR, US)
  • Pre-resection treatments allowed (TACE, RFA, PEI)
  • HCV-RNA positive (lower limit of detection: 100 copies/ml) regardless of blood titers or genotype

Exclusion Criteria:

  • HBsAg-positivity
  • Evidence of any active neoplastic site
  • Previous IFN or chemotherapy or treatment of other tumors
  • Severe surgical complication and/or causes of cirrhosis not related to HCV
  • Patient comorbidity (Hb <12 g/dl, HIV infection, autoimmune disease, psychiatric disorder, seizure, severe cardiovascular disease, poorly controlled diabetes, BMI >35)
  • Active alcohol intake (>80 g/day)

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): NCT00273247


Locations
Italy
National Cancer Institute
Milan, Italy, 20133
Sponsors and Collaborators
National Cancer Institute, Milan
Associazione Italiana per la Ricerca sul Cancro
Investigators
Principal Investigator: Vincenzo Mazzaferro, MD National Cancer Institute, Milan, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00273247     History of Changes
Other Study ID Numbers: INT-98-016
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: January 9, 2006
Last Verified: September 2005

Additional relevant MeSH terms:
Carcinoma
Hepatitis C
Carcinoma, Hepatocellular
Fibrosis
Liver Cirrhosis
Virus Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Pathologic Processes
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs