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Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer (EPOCH)

Primary Purpose

Colorectal Cancer Metastatic

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 Colorectal Cancer Metastatic

Eligibility Criteria

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

Inclusion Criteria

  • Must be male or female, 18 years of age or older, and of any ethnic or racial group
  • If primary tumor has not been resected, it must be clinically stable
  • Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy
  • Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
  • Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy
  • Tumor replacement <50% of total liver volume
  • Current Eastern Cooperative Oncology Group (ECOG) of 0-1 through screening to first treatment on study
  • Will have completed the first line chemotherapy regimen at least 14 days prior to initiation of 2nd line chemotherapy under the protocol
  • Patient is willing to participate in the study and has signed the study informed consent
  • Serum creatinine ≤ 2.0 mg/dL
  • Serum bilirubin up to 1.2 x upper limit of normal
  • Albumin ≥ 3.0 g/dL
  • Must have neutrophil count >1200/mm3 (1.2x109/L)

Exclusion Criteria

  • History of hepatic encephalopathy
  • Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (eg. closure device)
  • History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
  • Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
  • Cirrhosis or portal hypertension
  • Prior external beam radiation treatment to the liver
  • Prior intra-arterial liver directed therapy, including transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapy
  • Planned treatment with biological agents within 28 days prior to receiving TheraSphere
  • Planned liver directed therapy or radiation therapy
  • Intervention for, or compromise of, the Ampulla of Vater
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient
  • Significant life-threatening extra-hepatic disease, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be human immunodeficiency virus (HIV) positive or have acute hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • confirmed extra-hepatic metastases. Limited indeterminate extra-hepatic lesions in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion <1 cm; any number of lymph nodes with each individual nodes <1.5 cm)
  • Contraindications to the planned second line standard-of-care chemotherapy regimen
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study.
  • Participation in a clinical trial with an investigational therapy within 30 days prior to randomization
  • Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment

Sites / Locations

  • University of Alabama at Birmingham
  • University of California San Fransico, Moffitt Hospital
  • University of Colorado Denver Anschutz Medical Campus
  • Christiana Care Hospital
  • Lynn Clinical Research Center, Boca Raton Regional Hospital
  • University of Miami Miller School of Medicine, Florida
  • Moffit Cancer Center
  • Northwestern University
  • Rush University Medical Center
  • Carle Clinic
  • Indiana University School of Medicine
  • University of Louisville
  • University of Michigan Health System
  • Wayne State Harper Hospita Karmanos Cancer Institute
  • Spectrum Health
  • Beaumont Hospital
  • Allina Health, Virginia Piper Cancer Institute
  • Minneapolis
  • Mayo Clinic
  • Mallinckrodt Institute of Radiology
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester
  • Cleveland Clinic Foundation
  • The Ohio State University, Wexner Medical Center
  • Miami Valley Hospital
  • University of Pennsylvania
  • Aria Health
  • UT Southwestern Medical Center
  • UT MD Anderson Cancer Center
  • St. Marks Hospital
  • Sentara Norfolk General
  • University of Washington
  • Gundersen Medical Foundation
  • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
  • Aurora Research Institute
  • Medical University of Vienna
  • Onze-Lieve-Vrouwziekenuis VZW Campus Aalst
  • AZ - Sint Lucas
  • Universitair Ziekenhuis Gent
  • AZ Groeninge
  • Tom Baker Cancer Centre
  • QEII Health Services Center, Halifax Infirmary Site
  • London Regional Cancer program
  • Sunnybrook Health Sciences Centre
  • University Health Network , Mount Sinai Hospital
  • McGill University Health Center - Glen Site
  • Royal University Hospital
  • Hong Kong Sanatorium Hospital
  • Queen Mary Hospital
  • CHRU Montpellier - Hopital St Eloi
  • CUH d'Angers
  • CHU Toulouse, Hôpital Rangueil
  • Institut Bergognié
  • Hôpital Beaujon
  • Hôpital Henri Mondor
  • Centre Georges Francois Leclerc
  • Centre Hospitalier Lyon-Sud
  • Hôpital La Timone
  • CHU Nantes-Hôtel Dieu
  • CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2
  • CHU Bordeaux
  • Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie
  • Centre Eugene Marquis
  • Universitätsklinikum Bonn
  • Universitätsklinikum Essen
  • Medizinische Hochschule Hannover
  • SLK Kliniken, Heilbronn GmbH
  • Universitätsklinikum des Saarlandes
  • University Hospital of Leipzig
  • Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie
  • Eberhard-Karls-University Tübingen
  • Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi
  • Gangnam Severance Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • St. Mary's Hospital
  • Białostockie Centrum Onkologii
  • Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie
  • Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego
  • Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.
  • Szpital Kliniczny im. Heliodora Święcickiego
  • Centralny Szpital Kliniczny MSWiA
  • Centrum Onkologii - Instytut
  • Wojskowy Instytut Medyczny
  • National University Hospital
  • Hospital Universitario Fundación Alcorcón
  • Hospital Universitari Vall d'Hebron
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinic de Barcelona
  • Hospital Universitario del Henares
  • Hospital Universitario de Fuenlabrada
  • Hospital Universitario Virgen de las Nieves
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Ramon y Cajal
  • Hospital Fundación Jiménez Díaz
  • Hospital Universitario Puerta de Hierro
  • Hospital Regional Universitario de Málaga - Hospital General
  • Hospital Universitario Virgen de la Arrixaca
  • Avenida de Roma, s/n, Hospital Universitario Central de Asturias
  • Hospital Universitario Central de Asturias
  • Parc Taulí Sabadell Hospital Universitari
  • Hospital Universitari i Politècnic La Fe
  • HCU Lozano Blesa, Planta 11-Oncología-Secretaría
  • NHS Grampian - Aberdeen Royal Infirmary
  • Royal United Hospital Bath NHS Trust
  • The Clatterbrdige Cancer Centre NHSF Trust
  • Queen Elizabeth Hospital Cancer Centre
  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
  • Velindre Cancer Centre
  • Western General Hospital
  • Beatson Cancer Centre and University of Glasgow
  • University of Glasgow
  • Royal Surrey County Hospital
  • Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary
  • Leeds Hospitals NHS Trust
  • UCLH, University College London Hospitals
  • Guy's and St Thomas' NHS Foundation Trust
  • The Christie NHS Foundation Trust
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Nottingham University Hospital NHS Trust
  • Oxford University Hospitals NHS Foundation Trust Churchill Hospital
  • Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital
  • Western Park Hospital
  • Southampton General Hospital
  • Great Western Hospitals NHS Foundation Trust - The Great Western Hospital
  • Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
  • Walsall Healthcare NHS Trust - Manor Hospital
  • The Royal Wolverhampton NHS Trust - New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

Standard of care second-line chemotherapy plus TheraSphere

Standard of care second-line chemotherapy with no added therapy

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression Free survival by blinded independent central review per RECIST 1.1
Hepatic Progression-Free Survival (HPFS)
Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1

Secondary Outcome Measures

Overall Survival
Time from randomization until date of death due to any cause as reported by study site.

Full Information

First Posted
November 24, 2011
Last Updated
March 3, 2022
Sponsor
Boston Scientific Corporation
Collaborators
Biocompatibles UK Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01483027
Brief Title
Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer
Acronym
EPOCH
Official Title
A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (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 effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy 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
Colorectal Cancer Metastatic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Standard of care second-line chemotherapy plus TheraSphere
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care second-line chemotherapy with no added therapy
Intervention Type
Device
Intervention Name(s)
TheraSphere
Intervention Description
yttrium 90 microspheres
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression Free survival by blinded independent central review per RECIST 1.1
Time Frame
From date of randomization until the date of first documented progression, as defined by RECIST 1:1 or date of death from any cause, whichever comes first, assessed up to a minimum of 1 year follow up or until study completion
Title
Hepatic Progression-Free Survival (HPFS)
Description
Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1
Time Frame
Time from randomization until hepatic PD by BICR per RECIST 1.1 or death, whichever occurs first, assessed up to a minimum of 1 year follow up or study completion.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization until date of death due to any cause as reported by study site.
Time Frame
Time from date of randomization until date of death due to any cause; patients remaining on study post progression were followed until study completion; duration of follow up could be a few months to several years depending on when event was met.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Must be male or female, 18 years of age or older, and of any ethnic or racial group If primary tumor has not been resected, it must be clinically stable Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy Tumor replacement <50% of total liver volume Current Eastern Cooperative Oncology Group (ECOG) of 0-1 through screening to first treatment on study Will have completed the first line chemotherapy regimen at least 14 days prior to initiation of 2nd line chemotherapy under the protocol Patient is willing to participate in the study and has signed the study informed consent Serum creatinine ≤ 2.0 mg/dL Serum bilirubin up to 1.2 x upper limit of normal Albumin ≥ 3.0 g/dL Must have neutrophil count >1200/mm3 (1.2x109/L) Exclusion Criteria History of hepatic encephalopathy Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (eg. closure device) History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease Cirrhosis or portal hypertension Prior external beam radiation treatment to the liver Prior intra-arterial liver directed therapy, including transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapy Planned treatment with biological agents within 28 days prior to receiving TheraSphere Planned liver directed therapy or radiation therapy Intervention for, or compromise of, the Ampulla of Vater Clinically evident ascites (trace ascites on imaging is acceptable) Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient Significant life-threatening extra-hepatic disease, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be human immunodeficiency virus (HIV) positive or have acute hepatitis B virus (HBV) or hepatitis C virus (HCV) confirmed extra-hepatic metastases. Limited indeterminate extra-hepatic lesions in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion <1 cm; any number of lymph nodes with each individual nodes <1.5 cm) Contraindications to the planned second line standard-of-care chemotherapy regimen Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study. Participation in a clinical trial with an investigational therapy within 30 days prior to randomization Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary F Mulcahy, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of California San Fransico, Moffitt Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Denver Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Christiana Care Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lynn Clinical Research Center, Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Miami Miller School of Medicine, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
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
Carle Clinic
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
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
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State Harper Hospita Karmanos Cancer Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Allina Health, Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mallinckrodt Institute of Radiology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University, Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Aria Health
City
Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Marks Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Sentara Norfolk General
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Gundersen Medical Foundation
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora Research Institute
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Onze-Lieve-Vrouwziekenuis VZW Campus Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ - Sint Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
QEII Health Services Center, Halifax Infirmary Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
London Regional Cancer program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network , Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
McGill University Health Center - Glen Site
City
Montreal, Quebec
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Hong Kong Sanatorium Hospital
City
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
CHRU Montpellier - Hopital St Eloi
City
Montpellier
State/Province
Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
CUH d'Angers
City
Angers
State/Province
Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
CHU Toulouse, Hôpital Rangueil
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Bergognié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon cedex
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital La Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Nantes-Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Universitätsklinikum Bonn
City
Bonn,
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
SLK Kliniken, Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
University Hospital of Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Eberhard-Karls-University Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
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
St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Białostockie Centrum Onkologii
City
Bialystok
Country
Poland
Facility Name
Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie
City
Gliwice
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego
City
Grudziądz
Country
Poland
Facility Name
Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.
City
Lublin
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Święcickiego
City
Poznan
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warszawa
Country
Poland
Facility Name
Centrum Onkologii - Instytut
City
Warszawa
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona,
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario del Henares
City
Coslada
ZIP/Postal Code
28822
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital General 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 Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga - Hospital General
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia,
ZIP/Postal Code
30120
Country
Spain
Facility Name
Avenida de Roma, s/n, Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Parc Taulí Sabadell Hospital Universitari
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
HCU Lozano Blesa, Planta 11-Oncología-Secretaría
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
NHS Grampian - Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal United Hospital Bath NHS Trust
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
The Clatterbrdige Cancer Centre NHSF Trust
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital Cancer Centre
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson Cancer Centre and University of Glasgow
City
Glasgow,
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University of Glasgow
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Leeds Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
UCLH, University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospital NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LI
Country
United Kingdom
Facility Name
Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Western Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Great Western Hospitals NHS Foundation Trust - The Great Western Hospital
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Walsall Healthcare NHS Trust - Manor Hospital
City
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust - New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34541864
Citation
Mulcahy MF, Mahvash A, Pracht M, Montazeri AH, Bandula S, Martin RCG 2nd, Herrmann K, Brown E, Zuckerman D, Wilson G, Kim TY, Weaver A, Ross P, Harris WP, Graham J, Mills J, Yubero Esteban A, Johnson MS, Sofocleous CT, Padia SA, Lewandowski RJ, Garin E, Sinclair P, Salem R; EPOCH Investigators. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. J Clin Oncol. 2021 Dec 10;39(35):3897-3907. doi: 10.1200/JCO.21.01839. Epub 2021 Sep 20.
Results Reference
derived
PubMed Identifier
30664496
Citation
Chauhan N, Mulcahy MF, Salem R, Benson Iii AB, Boucher E, Bukovcan J, Cosgrove D, Laframboise C, Lewandowski RJ, Master F, El-Rayes B, Strosberg JR, Sze DY, Sharma RA. TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial. JMIR Res Protoc. 2019 Jan 17;8(1):e11545. doi: 10.2196/11545.
Results Reference
derived

Learn more about this trial

Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer

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