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

March 27, 2017 updated by: National Cancer Institute, Naples

Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • S. Orsola-Malpighi
      • Carpi, Italy
        • Ospedale Ramazzini di Carpi
      • Faenza, Italy
        • Osp. Civile Infermi
      • Firenze, Italy
        • Azienda Ospedaliera Careggi
      • Genova, Italy
        • IRCCS-Azienda Ospedaliera Universitaria San Martino-IST
      • Mantova, Italy
        • AO C. Poma
      • Meldola, Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Messina, Italy
        • A.O.U. G.Martino- Policlinico Universita di Messina
      • Milano, Italy
        • Istituto Nazionale Tumori
      • Napoli, Italy
        • Istituto Nazionale dei Tumori
      • Napoli, Italy
        • A.O.U. Federico II
      • Napoli, Italy
        • Ospedale Cardarelli
      • Napoli, Italy
        • AOU II Università di Napoli
      • Padova, Italy
        • Istituto Oncologico Veneto
      • Padova, Italy
        • Azienda Ospedaliera Universitaria di Padova
      • Palermo, Italy
        • A.O. Ospedali Riuniti Villa Sofia-Cervello
      • Parma, Italy
        • Azienda Ospedaliero Universitaria di Parma
      • Piacenza, Italy, Italy
        • Ospedale Guglielmo da Saliceto
      • Potenza, Italy
        • AO S. Carlo
      • Roma, Italy
        • Policlinico Universitario Tor Vergata
      • S. Giovanni Rotondo, Italy
        • Oncologia IRCCS - Casa Sollilevo Sofferenza
      • Sant'Anna di Ferrara, Italy
        • Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica
      • Trevigilio, Italy
        • A.O. Trevigilio - Caravaggio
    • BN
      • Benevento, BN, Italy
        • Azienda Ospedaliera G. Rummo
    • PA
      • Palermo, PA, Italy, 90127
        • Policlinico Giaccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
worst grade toxicity per patient
Time Frame: every 4 weeks
worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 4.03) per patient in both treatment arms
every 4 weeks
quality of life
Time Frame: every 4 weeks for 6 months
every 4 weeks for 6 months
progression free survival
Time Frame: every 8 weeks
every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

July 28, 2011

First Posted (ESTIMATE)

July 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOOST
  • EudraCT number 2009-013870-42 (REGISTRY: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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