Trial record 1 of 1 for:    NCT01556490
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Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by BTG International Inc.
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01556490
First received: March 13, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Unresectable Hepatocellular Carcinoma
Device: TheraSphere
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

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

Estimated Enrollment: 400
Study Start Date: March 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Standard-of-care sorafenib, with no added therapy
Experimental: Treatment group
Standard-of-care sorafenib plus TheraSphere
Device: TheraSphere
Yttrium 90 microspheres

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-related evaluation
  • Male or female patients over 18 years of age
  • Unresectable HCC confirmed by histology or by non-invasive AASLD criteria
  • Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
  • Child Pugh score ≤ 7 points
  • ECOG Performance Status score of ≤ 1
  • Life expectancy of 12 weeks or more
  • Eligible to receive standard-of-care sorafenib
  • Platelet count of > 50 x 10⁹ or > 50% prothrombin activity
  • Hemoglobin ≥ 85 mg/mL
  • Bilirubin ≤ 2 mg/dL
  • ALT and AST ≤ 5 X upper limit of normal
  • Amylase and lipase 1,5 X upper limit of normal
  • Serum creatinine ≤ 1.5 X upper limit of normal
  • INR < 2.0

Exclusion Criteria:

  • Main portal vein thrombosis
  • Eligible for curative treatment (ablation or transplantation)
  • Eligible for transarterial chemoembolization (TACE)
  • History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry
  • Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each
  • Risk of hepatic or renal failure
  • Tumor replacement > 70% of total liver volume based on visual estimation by investigator OR tumor replacement >50% of total liver volume in the presence of albumin <3 mg/dL
  • History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically
  • Contraindications to angiography and selective visceral catheterization
  • Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
  • Must not be taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone
  • Must not be taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)
  • Must not be taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
  • Must not be taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)
  • Must not be taking P-Gp substrates (e.g. Digoxin)
  • Prior liver resection < 6 months prior to randomization
  • Prior external beam radiation treatment to the liver or abdomen
  • Prior yttrium-90 microsphere treatment to the liver
  • Prior treatment with transarterial chemoembolization (TACE) or bland embolization < 6 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol
  • Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
  • Adverse effects due to prior therapy unresolved at randomization
  • Prior systemic treatment for the treatment of HCC, including sorafenib
  • History of pulmonary compromise, such as chronic obstructive pulmonary disease
  • Intervention for, or compromise of, the Ampulla of Vater
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Pregnancy or breast feeding
  • Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections including patients who are known HIV positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556490

Contacts
Contact: Medha Kelkar, MPharm, PMP 905-403-9901 ext 2667 medha.kelkar@theoremclinical.com

Locations
United States, Florida
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Bonnie Sauder, RN    813-745-3574    bonnie.sauder@moffitt.org   
Principal Investigator: Jennifer Sweeney, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlene del Castillo    312-695-1409    carlene.castillo@northwestern.edu   
Principal Investigator: Laura Kulik, MD         
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Jennifer Collier, RN, BSN    312-355-5112    collierj@uic.edu   
Principal Investigator: Ron Gaba, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Tamiko MaGee    317-278-7557    trmagee@iupui.edu   
Principal Investigator: Matthew S Johnson, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Schlegel, RN    502-629-3383    melissa.schlegel@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Colette Zack    313-576-9385    zackc@karmanos.org   
Contact: Courtney Wolf    313-576-9376    wolfc@karmanos.org   
Principal Investigator: Minsig Choi, MD         
Saint Mary's Healthcare Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathy Estkowski    616-685-5156    estkowk@mercyhealth.com   
Principal Investigator: Matthew Tiede, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Pickett    507-284-0586    pickett.jennifer@mayo.edu   
Principal Investigator: Lewis Roberts, MD         
United States, Oregon
Legacy Meridian Park Medical Center Recruiting
Tualatin, Oregon, United States, 97062
Contact: Susan Staat    503-413-8330    sstaat@lhs.org   
Principal Investigator: Jason Bauer, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nancy Pedano, RTR,CVR,RA    215-955-4129    nancy.pedano@jefferson.edu   
Principal Investigator: Colette Shaw, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Susan Lamson    412-864-3292    lamsons@upmc.edu   
Principal Investigator: David Gellar, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jolene Esposito    434-982-5037    jle2u@virginia.edu   
Principal Investigator: James Stone, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Obsy Tadesse    206-288-6439    otadesse@seattle.ca.org   
Principal Investigator: Siddharth Padia, MD         
Principal Investigator: William P Harris, MD         
Canada, Alberta
University of Alberta Hspital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Joanne McGoey    (780) 407 6912    joanne.mcgoey@albertahealthservices.ca   
Principal Investigator: Richard Owen, MD         
Canada, Quebec
McGill University Health Centre / Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Ayat Salman    (514) 934-1934 ext 36237    Ayat.Salman@MUHC.MCGILL.CA   
Principal Investigator: David Valenti, MD         
France
Centre Eugene Marquis Recruiting
Rennes, France, 35042 cedex
Principal Investigator: Eveline Boucher, MD         
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Riad Salem, MD, MBA Dept of Radiology Northwestern University
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01556490     History of Changes
Other Study ID Numbers: TS-103
Study First Received: March 13, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014