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

This study has been completed.
Sponsor:
Collaborator:
Associazione Italiana per la Ricerca sul Cancro
Information provided by:
National Cancer Institute, Milan
ClinicalTrials.gov Identifier:
NCT00273247
First received: January 5, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute, Milan:

Primary Outcome Measures:
  • Recurrence Free Survival

Secondary Outcome Measures:
  • Disease Specific Survival
  • Overall Patient Survival

Estimated Enrollment: 150
Study Start Date: June 1998
Estimated Study Completion Date: September 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by National Cancer Institute, Milan

Additional 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
Study First Received: January 5, 2006
Last Updated: January 5, 2006
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Virus Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013