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Advanced Adult Hepatocellular CarcinomaPhase 3BOOSTNCT01405573

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

A Phase 3 study testing sorafenib in people with Advanced Adult Hepatocellular Carcinoma, run by National Cancer Institute, Naples at 25 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Adult Hepatocellular Carcinoma
What is being tested?
sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
25 sitesItaly
Study dates
Jul 2011to Mar 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients who are unable or unwilling to participate in the study
  • Pregnant or lactating females
  • Hepatic encephalopathy of any grade

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

  • Azienda Ospedaliera G. Rummo

    Benevento, BN

  • S. Orsola-Malpighi

    Bologna

  • Ospedale Ramazzini di Carpi

    Carpi

  • Osp. Civile Infermi

    Faenza

  • Azienda Ospedaliera Careggi

    Florence

  • IRCCS-Azienda Ospedaliera Universitaria San Martino-IST

    Genova

  • AO C. Poma

    Mantua

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • A.O.U. G.Martino- Policlinico Universita di Messina

    Messina

  • Istituto Nazionale Tumori

    Milan

  • A.O.U. Federico II

    Naples

  • AOU II Università di Napoli

    Naples

  • Istituto Nazionale dei Tumori

    Naples

  • Ospedale Cardarelli

    Naples

  • Azienda Ospedaliera Universitaria di Padova

    Padova

  • Istituto Oncologico Veneto

    Padova

  • Policlinico Giaccone

    Palermo, PA, 90127

  • A.O. Ospedali Riuniti Villa Sofia-Cervello

    Palermo

  • Azienda Ospedaliero Universitaria di Parma

    Parma

  • Ospedale Guglielmo da Saliceto

    Piacenza, Italy

  • AO S. Carlo

    Potenza

  • Policlinico Universitario Tor Vergata

    Roma

  • Oncologia IRCCS - Casa Sollilevo Sofferenza

    S. Giovanni Rotondo

  • Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica

    Sant'Anna Di Ferrara

  • A.O. Trevigilio - Caravaggio

    Trevigilio

Other trials in Italy

About this study

Official title: 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).

Read the 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.

Being tested
Best Supportive Care, sorafenib
Keywords
Child Pugh B, first line

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Supportive CareOther

    Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.

  • sorafenibDrug

    400 mg twice a day

Study groups in NCT01405573
Study groupRoleWhat they receive
A: Best Supportive CareActive comparatorbest supportive care
Receives: Other: Best Supportive Care
B: Sorafenib 400 mg, twice a day + Best Supportive CareExperimentalsorafenib + best supportive care
Receives: Other: Best Supportive Care; Drug: sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 6 months

Secondary outcomes (3)

  1. worst grade toxicity per patient

    worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 4.03) per patient in both treatment arms

    Measured: every 4 weeks

  2. quality of life

    Measured: every 4 weeks for 6 months

  3. progression free survival

    Measured: every 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: lack of enrolment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01405573
Sponsor's protocol ID
BOOST
Other IDs
EudraCT number 2009-013870-42
Acronym
BOOST
Status last verified
Mar 2017
First submitted
26 Feb 2010
Last updated
28 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sorafenib in people with Advanced Adult Hepatocellular Carcinoma, run by National Cancer Institute, Naples at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: lack of enrolment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.

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