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

Primary Purpose

Unresectable Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TheraSphere
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Eastern Cooperative Oncology Group (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/L or > 50% prothrombin activity
  • Hemoglobin ≥ 8.5 g/dL
  • Bilirubin ≤ 2.5 mg/dL
  • Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)< 5 X upper limit of normal
  • Amylase or lipase ≤ 2X upper limit of normal
  • Serum creatinine ≤ 1.5 X upper limit of normal
  • International normalized ratio (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.
  • History of organ allograft
  • Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled severe hypertension or history of cardiac arrhythmias, congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, evidence of torsades de pointe, 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 Cytochrome P450 (CYP) 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
  • Taking any UDP-glucuronosyltransferase (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 chest, liver or abdomen
  • Prior yttrium-90 microsphere treatment to the liver
  • Prior treatment with transarterial chemoembolization (TACE) or bland embolization must have occurred >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol. For patients with tumor progression in the treatment field and /or lobe previously treated with TACE, vessels feeding the tumor(s) must be assessed for adequate blood flow using angiography (cone beam computerized tomography (CBCT) strongly recommended), and TACE or bland embolization must have been applied >6 months prior to randomization.
  • 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 given for more than 4 weeks during the 2 previous months prior to randomization, no prior sorafenib related toxicity
  • Evidence of pulmonary insufficiency or inadequately treated moderate grade or severe/very severe grade 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. Patients infected with HIV can be considered, however, they must be well managed and well controlled with undetectable viral load
  • Participation in concurrent clinical trials evaluating treatment intervention(s)

Sites / Locations

  • Banner - University Medical Center Phoenix
  • H Lee Moffitt Cancer Center
  • Northwestern Memorial Hospital
  • Rush University Medical Center
  • University of Illinois at Chicago
  • Northshore Hospital
  • Indiana University School of Medicine
  • University of Louisville
  • Wayne State Harper Hospital
  • Mayo Clinic Cancer Center
  • Montefiore Medical Center
  • Weill Cornell Medical Center
  • Miami Valley Hospital
  • Legacy Meridian Park Medical Center
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center
  • St Marks Hospital
  • University of Virginia Health System
  • Sentra Norfolk General Hospital
  • Seattle Cancer Care Alliance/University of Washington Medical Center
  • CUB Hôpital Erasme
  • CHU Liege
  • University of Alberta Hspital
  • Vancouver General Hospital
  • Toronto General Hospital
  • McGill University Health Centre / Royal Victoria Hospital
  • CHUM St. Luc
  • Hôpital Jean Verdier
  • CHU Estaing
  • APHP Hôpital Henri Mondor
  • CHU Dijon
  • CHU de Grenoble
  • CHU Lyon - Hopital de la Croix Rousse
  • Centre Léon-Bérard
  • Hopital de la Timone CHU
  • Hôpital Saint Eloi
  • CHU Hôtel-Dieu
  • CHU de Nice
  • Hôpital Haut-Lévêque, CHU Bordeaux
  • CHU de Poitiers
  • CHU Reims
  • Centre Eugene Marquis
  • CHU Amiens Picardie - Hôpital Sud
  • Hôpital de Hautepierre
  • Hôpital Purpan
  • CHU Nancy
  • Institut Gustave Roussy
  • Hôpital Universitaire Paul Brousse
  • Universitätsklinikum Bonn
  • Universitaetsklinikum Essen
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie
  • Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie
  • Azienda Ospedaliero -Universitaria di Bologna
  • St. Mary Hospital
  • Kyungpook National University Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • VUMC
  • AMC
  • UMCG
  • LUMC
  • MUMC
  • Erasmus MC
  • National University Hospital
  • Hospital Infanta Cristina
  • Hospital Clinic i Provincial
  • Hospital de la Santa Creu i Sant Pau
  • UDIAT Corporacio Parc Tauli
  • Hospital Universitario Reina Sofia
  • Hospital Virgen de las Nieves
  • Hospital Universitario Gregorio Marañón
  • Hospital Universitario Ramon y Cajal
  • Hospital Clínico San Carlos
  • Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.
  • Hosptal Universitario Central de Asturias (nuevo HUCA)
  • Hospital Clínico Universitario
  • H. Virgen del Rocio
  • Hospital Universitario y Politecnico La Fe
  • Hospital Clínico Universitario de Valladolid
  • Hospital Clínico Universitario Lozano Blesa
  • New Queen Elizabeth Hospital Birmingham
  • Addenbrooks Hospital
  • Edinburgh Cancer Centre
  • Royal Surrey Country Hospital
  • Royal Liverpool University Hospital
  • University College London Cancer Institute
  • King's College Hospital;
  • Imperial College London
  • Christie Hospital
  • Freeman Hospital
  • Weston Park Hospital, Sheffield

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Treatment group

Arm Description

Standard-of-care sorafenib, with no added therapy

Standard-of-care sorafenib plus TheraSphere

Outcomes

Primary Outcome Measures

Overall survival
The interval between the randomization date and the date of death for any cause

Secondary Outcome Measures

Full Information

First Posted
March 13, 2012
Last Updated
February 16, 2023
Sponsor
Boston Scientific Corporation
Collaborators
Biocompatibles UK Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01556490
Brief Title
Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer
Acronym
STOP-HCC
Official Title
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Biocompatibles UK Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard-of-care sorafenib, with no added therapy
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Standard-of-care sorafenib plus TheraSphere
Intervention Type
Device
Intervention Name(s)
TheraSphere
Intervention Description
Yttrium 90 microspheres
Primary Outcome Measure Information:
Title
Overall survival
Description
The interval between the randomization date and the date of death for any cause
Time Frame
From time of randomization up to 45 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Eastern Cooperative Oncology Group (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/L or > 50% prothrombin activity Hemoglobin ≥ 8.5 g/dL Bilirubin ≤ 2.5 mg/dL Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)< 5 X upper limit of normal Amylase or lipase ≤ 2X upper limit of normal Serum creatinine ≤ 1.5 X upper limit of normal International normalized ratio (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. History of organ allograft Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled severe hypertension or history of cardiac arrhythmias, congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, evidence of torsades de pointe, 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 Cytochrome P450 (CYP) 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide) Taking any UDP-glucuronosyltransferase (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 chest, liver or abdomen Prior yttrium-90 microsphere treatment to the liver Prior treatment with transarterial chemoembolization (TACE) or bland embolization must have occurred >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol. For patients with tumor progression in the treatment field and /or lobe previously treated with TACE, vessels feeding the tumor(s) must be assessed for adequate blood flow using angiography (cone beam computerized tomography (CBCT) strongly recommended), and TACE or bland embolization must have been applied >6 months prior to randomization. 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 given for more than 4 weeks during the 2 previous months prior to randomization, no prior sorafenib related toxicity Evidence of pulmonary insufficiency or inadequately treated moderate grade or severe/very severe grade 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. Patients infected with HIV can be considered, however, they must be well managed and well controlled with undetectable viral load Participation in concurrent clinical trials evaluating treatment intervention(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riad Salem, MD, MBA
Organizational Affiliation
Dept of Radiology Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner - University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2612
Country
United States
Facility Name
H Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northshore Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Wayne State Harper Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Legacy Meridian Park Medical Center
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
St Marks Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentra Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Cancer Care Alliance/University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
CUB Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Alberta Hspital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X6
Country
Canada
Facility Name
McGill University Health Centre / Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHUM St. Luc
City
Montréal
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Hôpital Jean Verdier
City
Bondy
ZIP/Postal Code
93140
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
APHP Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHU Lyon - Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Léon-Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital de la Timone CHU
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Haut-Lévêque, CHU Bordeaux
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU Reims
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
CHU Amiens Picardie - Hôpital Sud
City
Salouël
ZIP/Postal Code
80480
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Nancy
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Hôpital Universitaire Paul Brousse
City
Villejuif
Country
France
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Azienda Ospedaliero -Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
St. Mary Hospital
City
Daegu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
MUMC
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
UDIAT Corporacio Parc Tauli
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hosptal Universitario Central de Asturias (nuevo HUCA)
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
H. Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
New Queen Elizabeth Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Addenbrooks Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Surrey Country Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L69 3GA
Country
United Kingdom
Facility Name
University College London Cancer Institute
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital;
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Weston Park Hospital, Sheffield
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30111528
Citation
Chauhan N, Bukovcan J, Boucher E, Cosgrove D, Edeline J, Hamilton B, Kulik L, Master F, Salem R. Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 15;7(8):e11234. doi: 10.2196/11234.
Results Reference
derived
Links:
URL
http://www.theraspheretrials.com/stop-hcc
Description
Trial-specific website

Learn more about this trial

Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

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