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

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ClinicalTrials.gov Identifier: NCT01556490
Recruitment Status : Active, not recruiting
First Posted : March 16, 2012
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.

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.

Condition or disease Intervention/treatment Phase
Unresectable Hepatocellular Carcinoma Device: TheraSphere Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : March 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: From time of randomization up to 45 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 ≥ 8.5 g/dL
  • Bilirubin ≤ 2.5 mg/dL
  • ALT and AST< 5 X upper limit of normal
  • Amylase and lipase ≤ 2X 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)
  • 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, evidence of severe or systemic diseases, uncontrolled hypertension or history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
  • Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone
  • Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)
  • Taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
  • Taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)
  • Taking P-Gp substrates (e.g. Digoxin)
  • Prior liver resection must have taken >2 months prior to randomization
  • Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period
  • 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 >2 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
  • Evidence of pulmonary insufficiency or clinically evident 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
  • Participation in concurrent clinical trials evaluating treatment intervention(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556490


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Locations
United States, Florida
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Northshore Hospital
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Michigan
Wayne State Harper Hospital
Detroit, Michigan, United States, 48201
Saint Mary's Healthcare
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
United States, Ohio
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oregon
Legacy Meridian Park Medical Center
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
St Marks Hospital
Salt Lake City, Utah, United States, 84124
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sentra Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle Cancer Care Alliance/University of Washington Medical Center
Seattle, Washington, United States, 98195
Belgium
OLV Hospital Aalst
Aalst, Belgium, 9300
CUB Hôpital Erasme
Bruxelles, Belgium, 1070
CHU Liege
Liege, Belgium, 4000
Canada, Alberta
University of Alberta Hspital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1X6
Canada, Quebec
McGill University Health Centre / Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Canada
CHUM St. Luc
Montréal, Canada, H2X 3J4
China
Prince of Wales Hospital
Hong Kong, China, 852
France
Hôpital Jean Verdier
Bondy, France, 93140
APHP Hôpital Henri Mondor
Creteil, France, 94000
CHU Dijon
Dijon, France, 21000
CHU de Grenoble
La Tronche, France, 38700
CHU Lyon - Hopital de la Croix Rousse
Lyon, France, 69004
Centre Léon-Bérard
Lyon, France, 69373
Hopital de la Timone CHU
Marseille, France, 13385
Hôpital Saint Eloi
Montpellier, France, 34295
CHU Hôtel-Dieu
Nantes, France, 44093
CHU de Nice
Nice, France, 06202
Hôpital Haut-Lévêque, CHU Bordeaux
Pessac Cedex, France, 33604
CHU de Poitiers
Poitiers, France, 86000
CHU Reims
Reims Cedex, France, 51092
Centre Eugene Marquis
Rennes Cedex, France, 35042
CHU Amiens Picardie - Hôpital Sud
Salouël, France, 80480
Hôpital de Hautepierre
Strasbourg, France, 67200
Hôpital Purpan
Toulouse, France, 31059
CHU Nancy
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Hôpital Universitaire Paul Brousse
Villejuif, France
Germany
Universitätsklinikum Bonn
Bonn, Germany, 53105
Universitaetsklinikum Essen
Essen, Germany, 45122
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie
Leipzig, Germany, 04103
Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie
Tübingen, Germany, 72076
Italy
Azienda Ospedaliero -Universitaria di Bologna
Bologna, Italy, 40138
Korea, Republic of
St. Mary Hospital
Daegu, Korea, Republic of, 137-701
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
DaeJeon St.Mary's Hopital
Daejeon, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Netherlands
VUMC
Amsterdam, Netherlands, 1081 HV
AMC
Amsterdam, Netherlands, 1105 AZ
UMCG
Groningen, Netherlands, 9713 GZ
LUMC
Leiden, Netherlands, 2333 ZA
MUMC
Maastricht, Netherlands, 6229 HX
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Singapore
National University Hospital
Singapore, Singapore, 119228
Spain
Hospital Infanta Cristina
Badajoz, Spain, 06006
Hospital Clinic i Provincial
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
UDIAT Corporacio Parc Tauli
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.
Murcia, Spain, 30120
Hosptal Universitario Central de Asturias (nuevo HUCA)
Oviedo, Spain, 33011
Hospital Clínico Universitario
Salamanca, Spain, 37007
H. Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
United Kingdom
Addenbrooks Hospital
Cambridge, United Kingdom, CB2 0QQ
Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
Royal Surrey Country Hospital
Guildford, United Kingdom, GU2 7XX
Royal Liverpool University Hospital
Liverpool, United Kingdom, L69 3GA
University College London Cancer Institute
London, United Kingdom, NW3 2QG
King's College Hospital;
London, United Kingdom, SE5 9RS
Imperial College London
London, United Kingdom, W12 0NN
Christie Hospital
Manchester, United Kingdom, M20 4BX
Northern Centre Cancer Care
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Weston Park Hospital, Sheffield
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Riad Salem, MD, MBA Dept of Radiology Northwestern University

Additional Information:
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01556490     History of Changes
Other Study ID Numbers: TS-103
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

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