Single administration of Selective Internal Radiation Therapy versus continuous treatment with sorafeNIB in locally advanced hepatocellular carcinoma SIRveNIB: study protocol for a phase iii randomized controlled trialReport as inadecuate




Single administration of Selective Internal Radiation Therapy versus continuous treatment with sorafeNIB in locally advanced hepatocellular carcinoma SIRveNIB: study protocol for a phase iii randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 16:856

Medical and radiation oncology

Abstract

BackgroundApproximately 20 % of hepatocellular carcinoma HCC patients diagnosed in the early stages may benefit from potentially curative ablative therapies such as surgical resection, transplantation or radiofrequency ablation. For patients not eligible for such options, prognosis is poor. Sorafenib and Selective Internal Radiation Therapy SIRT are clinically proven treatment options in patients with unresectable HCC, and this study aims to assess overall survival following either SIRT or Sorafenib therapy for locally advanced HCC patients.

MethodsThis investigator-initiated, multi-centre, open-label, randomized, controlled trial will enrol 360 patients with locally advanced HCC, as defined by Barcelona Clinic Liver Cancer stage B or stage C, without distant metastases, and which is not amenable to immediate curative treatment. Exclusion criteria include previous systemic therapy, metastatic disease, complete occlusion of the main portal vein, or a Child-Pugh score of >7. Eligible patients will be randomised 1:1 and stratified by centre and presence or absence of portal vein thrombosis to receive either a single administration of SIRT using yttrium-90 resin microspheres SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia targeted at HCC in the liver by the trans-arterial route or continuous oral Sorafenib Nexavar®, Bayer Pharma AG, Berlin, Germany at a dose of 400 mg twice daily until disease progression, no further response, complete regression or unacceptable toxicity. Patients for both the Sorafenib and SIRT arms will be followed-up every 4 weeks for the first 3 months and 12 weekly thereafter. Overall survival is the primary endpoint, assessed for the intention-to-treat population. Secondary endpoints are tumour response rate, time-to-tumour progression, progression free survival, quality of life and down-staging to receive potentially curative therapy.

DiscussionDefinitive data comparing these two therapies will help to determine clinical practice in the large group of patients with locally advanced HCC and improve outcomes for such patients.

Trial registrationClinicalTrials.gov identifier, NCT01135056, first received 24, May 2010.

KeywordsAdvanced hepatocellular carcinoma Liver cancer Radioembolisation Selective internal radiation therapy SIR-Spheres Sorafenib Systemic therapy Asia-Pacific Randomized controlled trial Phase III AbbreviationsTcTechnetium-99 m

AASLDAmerican Association for the Study of Liver Diseases

ALPAlkaline phosphatase

ALTAlanine aminotransferase

ASTAspartate transaminase

BCLCBarcelona clinic liver cancer

BORBest overall response

CIConfidence interval

CRComplete response

CTComputed tomography

ECOGEastern Cooperative Oncology Group

HCCHepatocellular carcinoma

HRQoLHealth-related quality of life

INRInternational normalised ratio

ITTIntention to treat

MRIMagnetic resonance imaging

NCI CTCAENational Cancer Institute Common Terminology Criteria for Adverse Events

OSOverall survival

PFSProgression-free survival

PRPartial response

PVTPortal vein thrombosis

RECISTResponse Evaluation Criteria in Solid Tumours

SARAHSorAfenib versus Radioembolisation in Advanced Hepatocellular carcinoma

SHARPSorafenib Hepatocellular carcinoma Assessment Randomized Protocol

SIRTSelective Internal Radiation Therapy

SIRveNIBSelective internal radiation therapy SIRT VErsus SorafeNIB in locally advanced hepatocellular carcinoma

TTPTime to progression

ULNUpper limit of normal

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Author: Mihir Gandhi - Su Pin Choo - Choon Hua Thng - Say Beng Tan - Albert Su Chong Low - Peng Chung Cheow - Anthony Soon W

Source: https://link.springer.com/



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