Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)

This study is currently recruiting participants.

Verified May 2013 by Nordion (Canada) Inc.

Sponsor:

Information provided by (Responsible Party):

Nordion (Canada) Inc.

ClinicalTrials.gov Identifier:

NCT01556490

First received: March 13, 2012

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2012

Last Updated Date

May 1, 2013

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival [ Time Frame: From time of randomization up to 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01556490 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

Official Title ^ICMJE

A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

Brief Summary

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Unresectable Hepatocellular Carcinoma

Intervention ^ICMJE

Device: TheraSphere

Yttrium 90 microspheres

Study Arm (s)

No Intervention: Control group
Standard-of-care sorafenib, with no added therapy
Experimental: Treatment group
Standard-of-care sorafenib plus TheraSphere

Intervention: Device: TheraSphere

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

October 2016

Estimated Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Unresectable advanced HCC not amenable to curative procedures, with planned standard-of-care sorafenib therapy

Exclusion Criteria:

Main portal vein thrombosis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Medha Kelkar, MPharm, PMP

905-403-9901 ext 2667

medha.kelkar@theoremclinical.com

Location Countries ^ICMJE

United States, Canada, France

Administrative Information

NCT Number ^ICMJE

NCT01556490

Other Study ID Numbers ^ICMJE

TS-103

Has Data Monitoring Committee

Yes

Responsible Party

Nordion (Canada) Inc.

Study Sponsor ^ICMJE

Nordion (Canada) Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Riad Salem, MD, MBA

Dept of Radiology Northwestern University

Information Provided By

Nordion (Canada) Inc.

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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