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

Primary Purpose

Advanced Adult Hepatocellular Carcinoma

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Best Supportive Care

sorafenib

About this trial

This is an interventional treatment trial for Advanced Adult Hepatocellular Carcinoma focused on measuring Child Pugh B, first line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Azienda Ospedaliera G. Rummo
Policlinico Giaccone
S. Orsola-Malpighi
Ospedale Ramazzini di Carpi
Osp. Civile Infermi
Azienda Ospedaliera Careggi
IRCCS-Azienda Ospedaliera Universitaria San Martino-IST
AO C. Poma
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
A.O.U. G.Martino- Policlinico Universita di Messina
Istituto Nazionale Tumori
A.O.U. Federico II
AOU II Università di Napoli
Istituto Nazionale dei Tumori
Ospedale Cardarelli
Azienda Ospedaliera Universitaria di Padova
Istituto Oncologico Veneto
A.O. Ospedali Riuniti Villa Sofia-Cervello
Azienda Ospedaliero Universitaria di Parma
Ospedale Guglielmo da Saliceto
AO S. Carlo
Policlinico Universitario Tor Vergata
Oncologia IRCCS - Casa Sollilevo Sofferenza
Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica
A.O. Trevigilio - Caravaggio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A: Best Supportive Care

B: Sorafenib 400 mg, twice a day + Best Supportive Care

Arm Description

best supportive care

sorafenib + best supportive care

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

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

quality of life

progression free survival

Full Information

NCT ID

NCT01405573

First Posted

February 26, 2010

Last Updated

March 27, 2017

Sponsor

National Cancer Institute, Naples

1. Study Identification

Unique Protocol Identification Number

NCT01405573

Brief Title

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

Acronym

BOOST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

lack of enrolment

Study Start Date

July 2011 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Adult Hepatocellular Carcinoma

Keywords

Child Pugh B, first line

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Best Supportive Care

Arm Type

Active Comparator

Arm Description

best supportive care

Arm Title

B: Sorafenib 400 mg, twice a day + Best Supportive Care

Arm Type

Experimental

Arm Description

sorafenib + best supportive care

Intervention Type

Other

Intervention Name(s)

Best Supportive Care

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sorafenib

Intervention Description

400 mg twice a day

Primary Outcome Measure Information:

Title

overall survival

Time Frame

6 months

Secondary Outcome Measure Information:

Title

worst grade toxicity per patient

Description

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

Time Frame

every 4 weeks

Title

quality of life

Time Frame

every 4 weeks for 6 months

Title

progression free survival

Time Frame

every 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: