Study Stopped
lack of enrolment
Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
BOOST
Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial
2 other identifiers
interventional
35
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2011
Longer than P75 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 28, 2017
March 1, 2017
5.7 years
February 26, 2010
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
6 months
Secondary Outcomes (3)
worst grade toxicity per patient
every 4 weeks
quality of life
every 4 weeks for 6 months
progression free survival
every 8 weeks
Study Arms (2)
A: Best Supportive Care
ACTIVE COMPARATORbest supportive care
B: Sorafenib 400 mg, twice a day + Best Supportive Care
EXPERIMENTALsorafenib + best supportive care
Interventions
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Policlinico Giaccone
Palermo, PA, 90127, Italy
S. Orsola-Malpighi
Bologna, Italy
Ospedale Ramazzini di Carpi
Carpi, Italy
Osp. Civile Infermi
Faenza, Italy
Azienda Ospedaliera Careggi
Florence, Italy
IRCCS-Azienda Ospedaliera Universitaria San Martino-IST
Genova, Italy
AO C. Poma
Mantova, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
A.O.U. G.Martino- Policlinico Universita di Messina
Messina, Italy
Istituto Nazionale Tumori
Milan, Italy
A.O.U. Federico II
Napoli, Italy
AOU II Università di Napoli
Napoli, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Ospedale Cardarelli
Napoli, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, Italy
Istituto Oncologico Veneto
Padua, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Italy, Italy
AO S. Carlo
Potenza, Italy
Policlinico Universitario Tor Vergata
Roma, Italy
Oncologia IRCCS - Casa Sollilevo Sofferenza
S. Giovanni Rotondo, Italy
Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica
Sant'Anna Di Ferrara, Italy
A.O. Trevigilio - Caravaggio
Trevigilio, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
July 29, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 28, 2017
Record last verified: 2017-03