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Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (HCC)

NCT01135056 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2018-04-24

No results posted yet for this study

Summary

The primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS).

The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy.

Conditions

Interventions

DEVICE

SIR-Spheres

One time treatment. Dose administered based on tumour volume. Each vial is 3.0GBq.

DRUG

Sorafenib tosylate

Oral Tablet, 400mg B.i.d, until progression or unacceptable toxicity develops

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    collaborator OTHER

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Singapore Clinical Research Institute

    collaborator OTHER

  • Sirtex Medical

    collaborator INDUSTRY

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Pierce KH Chow, MBBS, PhD · National Cancer Centre, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Brunei
  • Burma
  • China
  • Indonesia
  • Malaysia
  • Mongolia
  • New Zealand
  • Philippines
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135056 on ClinicalTrials.gov