Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma (BOOST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01405573
First received: February 26, 2010
Last updated: November 25, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma (HCC) with impaired liver function (Child B).

Condition Intervention Phase
Advanced Adult Hepatocellular Carcinoma
Other: Best Supportive Care
Drug: sorafenib
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: Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • worst grade toxicity per patient [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 4.03) per patient in both treatment arms

  • quality of life [ Time Frame: every 4 weeks for 6 months ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: Best Supportive Care
best supportive care
Other: Best Supportive Care
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
Experimental: B: Sorafenib 400 mg, twice a day + Best Supportive Care
sorafenib + best supportive care
Other: Best Supportive Care
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
Drug: sorafenib
400 mg twice a day

Detailed Description:
Hepatocellular carcinoma (HCC) is the third cause of death for cancer in the world with an increasing incidence. No systemic therapy has proven effective in patients with advanced HCC until 2007, when results of the SHARP trial were presented. In this trial, the orally active multi-kinase inhibitor sorafenib (800 mg/day) significantly prolonged survival compared with placebo in patients with advanced HCC and good liver function (Child A). The same authors concluded that the effect of the drug in the population of patients with more impaired liver function should be further studied.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of hepatic cell carcinoma (HCC) according to the AASLD- EASL criteria
  • Age >18 years
  • Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments)
  • Liver function classified as Child-Pugh class B
  • ECOG performance status < or = 2
  • Life expectancy of at least 2 months
  • Adequate contraception for fertile male and female patients
  • Signed informed consent

Exclusion Criteria:

  • Prior exposure to sorafenib or antiangiogenesis drugs
  • Concomitant diseases that contraindicate the use of sorafenib
  • Gastro-intestinal bleeding in the previous 30 days
  • Altered renal function(creatinine > 1.5 x ULN), or haematological function (platelet count < 60 x 10^9/L, hemoglobin < 9 g/dl)
  • Serious active infections (> grade 2 CTCAE version 3.0)
  • Congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
  • Patients who are unable or unwilling to participate in the study
  • Pregnant or lactating females
  • Hepatic encephalopathy of any grade
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405573

Contacts
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Massimo Di Maio, M.D. +39 081 5903383 massimo.dimaio@usc-intnapoli.net

Locations
Italy
Azienda Ospedaliera G. Rummo Recruiting
Benevento, BN, Italy
Policlinico Giaccone Recruiting
Palermo, PA, Italy, 90127
S. Orsola-Malpighi Recruiting
Bologna, Italy
Ospedale Ramazzini di Carpi Recruiting
Carpi, Italy
Osp. Civile Infermi Recruiting
Faenza, Italy
Azienda Ospedaliera Careggi Not yet recruiting
Firenze, Italy
IRCCS-Azienda Ospedaliera Universitaria San Martino-IST Recruiting
Genova, Italy
AO C. Poma Recruiting
Mantova, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy
A.O.U. G.Martino- Policlinico Universita di Messina Recruiting
Messina, Italy
Istituto Nazionale Tumori Not yet recruiting
Milano, Italy
A.O.U. Federico II Recruiting
Napoli, Italy
AOU II Università di Napoli Recruiting
Napoli, Italy
Istituto Nazionale dei Tumori Recruiting
Napoli, Italy
Ospedale Cardarelli Recruiting
Napoli, Italy
Azienda Ospedaliera Universitaria di Padova Recruiting
Padova, Italy
Istituto Oncologico Veneto Recruiting
Padova, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello Recruiting
Palermo, Italy
Azienda Ospedaliero Universitaria di Parma Not yet recruiting
Parma, Italy
Ospedale Guglielmo da Saliceto Recruiting
Piacenza, Italy, Italy
AO S. Carlo Recruiting
Potenza, Italy
Policlinico Universitario Tor Vergata Not yet recruiting
Roma, Italy
Oncologia IRCCS - Casa Sollilevo Sofferenza Recruiting
S. Giovanni Rotondo, Italy
Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica Recruiting
Sant'Anna di Ferrara, Italy
A.O. Trevigilio - Caravaggio Recruiting
Trevigilio, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Bruno Daniele, M.D. Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Principal Investigator: Ciro Gallo, M.D., Ph.D Second University of Naples, Italy; Chair of Medical Statistics
Principal Investigator: Antonio Gasbarrini, M.D. Università Cattolica del S. Cuore, Policlinico Gemelli, Roma
Principal Investigator: Giacomo Carteni', M.D. Ospedale Antonio Cardarelli, Napoli
  More Information

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01405573     History of Changes
Other Study ID Numbers: BOOST  EudraCT number 2009-013870-42 
Study First Received: February 26, 2010
Last Updated: November 25, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
Child Pugh B
first line

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016