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

Sponsors and Collaborators:	National Cancer Institute, Milan Associazione Italiana per la Ricerca sul Cancro
Information provided by:	National Cancer Institute, Milan
ClinicalTrials.gov Identifier:	NCT00273247

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Cirrhosis Hepatitis Hepatitis C

Drug Information available for: Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Interferons

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 National Clinical Trials Identifier (NCT ID):

Mazzaferro V, Romito R, Schiavo M, Mariani L, Camerini T, Bhoori S, Capussotti L, Calise F, Pellicci R, Belli G, Tagger A, Colombo M, Bonino F, Majno P, Llovet JM; HCC Italian Task Force. Prevention of hepatocellular carcinoma recurrence with alpha-interferon after liver resection in HCV cirrhosis. Hepatology. 2006 Dec;44(6):1543-54.

Study ID Numbers:	INT-98-016
Study First Received:	January 5, 2006
Last Updated:	January 5, 2006
ClinicalTrials.gov Identifier:	NCT00273247 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Anti-Infective Agents
Liver Diseases
Immunologic Factors
Fibrosis
Carcinoma, Hepatocellular
Hepatitis, Viral, Human
Liver Cirrhosis
Liver Neoplasms
Hepatitis C
Hepatocellular Carcinoma
Interferon-alpha
Digestive System Neoplasms
Interferons

Adjuvants, Immunologic
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Carcinoma
Virus Diseases
Hepatitis
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Interferon Alfa-2a
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Immunologic Factors
Flaviviridae Infections
Antineoplastic Agents
Fibrosis
Carcinoma, Hepatocellular
Physiological Effects of Drugs
Hepatitis, Viral, Human
Liver Cirrhosis
Infection
Liver Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses

Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Interferon-alpha
RNA Virus Infections
Neoplasms by Histologic Type
Digestive System Neoplasms
Growth Substances
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Carcinoma
Virus Diseases
Hepatitis

ClinicalTrials.gov processed this record on September 01, 2009