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

Sponsor

National Cancer Institute, Naples (Other)

Overall Status

Terminated

CT.gov ID

NCT01405573

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Advanced Adult Hepatocellular Carcinoma	Other: Best Supportive Care Drug: sorafenib	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

overall survival [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera G. Rummo	Benevento	BN	Italy
2	Policlinico Giaccone	Palermo	PA	Italy	90127
3	S. Orsola-Malpighi	Bologna		Italy
4	Ospedale Ramazzini di Carpi	Carpi		Italy
5	Osp. Civile Infermi	Faenza		Italy
6	Azienda Ospedaliera Careggi	Firenze		Italy
7	IRCCS-Azienda Ospedaliera Universitaria San Martino-IST	Genova		Italy
8	AO C. Poma	Mantova		Italy
9	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola		Italy
10	A.O.U. G.Martino- Policlinico Universita di Messina	Messina		Italy
11	Istituto Nazionale Tumori	Milano		Italy
12	A.O.U. Federico II	Napoli		Italy
13	AOU II Università di Napoli	Napoli		Italy
14	Istituto Nazionale dei Tumori	Napoli		Italy
15	Ospedale Cardarelli	Napoli		Italy
16	Azienda Ospedaliera Universitaria di Padova	Padova		Italy
17	Istituto Oncologico Veneto	Padova		Italy
18	A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo		Italy
19	Azienda Ospedaliero Universitaria di Parma	Parma		Italy
20	Ospedale Guglielmo da Saliceto	Piacenza		Italy	Italy
21	AO S. Carlo	Potenza		Italy
22	Policlinico Universitario Tor Vergata	Roma		Italy
23	Oncologia IRCCS - Casa Sollilevo Sofferenza	S. Giovanni Rotondo		Italy
24	Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica	Sant'Anna di Ferrara		Italy
25	A.O. Trevigilio - Caravaggio	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