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

March 3, 2022 updated by: Boston Scientific Corporation

A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

428

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-Vrouwziekenuis VZW Campus Aalst
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Gent, Belgium, 9000
        • AZ - Sint Lucas
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Services Center, Halifax Infirmary Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network , Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Quebec, Canada, H4A 3J1
        • McGill University Health Center - Glen Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • China
      • Hong Kong, China
        • Queen Mary Hospital
      • Hong Kong, China
        • Hong Kong Sanatorium Hospital
  • France
      • Bordeaux, France, 33076
        • Institut Bergognié
      • Clichy, France, 92110
        • Hopital Beaujon
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Dijon cedex, France, 21000
        • Centre Georges François Leclerc
      • Lyon, France, 69003
        • Centre Hospitalier Lyon-Sud
      • Marseille, France, 13005
        • Hôpital La Timone
      • Nantes, France, 44093
        • CHU Nantes-Hotel Dieu
      • Nice, France, 6202
        • CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2
      • Pessac, France, 33600
        • CHU Bordeaux
      • Poitiers, France, 86000
        • Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie
      • Rennes, France, 35000
        • Centre Eugène Marquis
    • Cedex 5
      • Montpellier, Cedex 5, France, 34295
        • CHRU Montpellier - Hopital St Eloi
    • Cedex 9
      • Angers, Cedex 9, France, 49933
        • CUH d'Angers
      • Toulouse, Cedex 9, France, 31059
        • CHU Toulouse, Hôpital Rangueil
  • Germany
      • Bonn,, Germany, 53127
        • Universitätsklinikum Bonn
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heilbronn, Germany, 74078
        • SLK Kliniken, Heilbronn GmbH
      • Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Leipzig, Germany, 04103
        • University Hospital of Leipzig
      • Marburg, Germany, 35043
        • Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie
      • Tübingen, Germany, 72076
        • Eberhard-Karls-University Tübingen
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • St. Mary's Hospital
  • Poland
      • Bialystok, Poland
        • Białostockie Centrum Onkologii
      • Gliwice, Poland
        • Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie
      • Grudziądz, Poland
        • Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego
      • Lublin, Poland
        • Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.
      • Poznan, Poland
        • Szpital Kliniczny im. Heliodora Swiecickiego
      • Warszawa, Poland
        • Centralny Szpital Kliniczny MSWiA
      • Warszawa, Poland
        • Centrum Onkologii - Instytut
      • Warszawa, Poland
        • Wojskowy Instytut Medyczny
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • Spain
      • Alcorcón, Spain, 28922
        • Hospital Universitario Fundación Alcorcón
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8036
        • Hospital Clinic De Barcelona
      • Barcelona,, Spain
        • Hospital Universitari Vall d'Hebron
      • Coslada, Spain, 28822
        • Hospital Universitario del Henares
      • Fuenlabrada, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Fundación Jimenez Diaz
      • Madrid, Spain, 28220
        • Hospital Universitario Puerta de Hierro
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga - Hospital General
      • Murcia,, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Oviedo, Spain, 33011
        • Avenida de Roma, s/n, Hospital Universitario Central de Asturias
      • Sabadell, Spain, 8208
        • Parc Taulí Sabadell Hospital Universitari
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Zaragoza, Spain, 50009
        • HCU Lozano Blesa, Planta 11-Oncología-Secretaría
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • NHS Grampian - Aberdeen Royal Infirmary
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital Bath NHS Trust
      • Bebington, United Kingdom, CH63 4JY
        • The Clatterbrdige Cancer Centre NHSF Trust
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital Cancer Centre
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS2 8ED
        • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G12 0YN
        • University of Glasgow
      • Glasgow,, United Kingdom, G12 0YN
        • Beatson Cancer Centre and University of Glasgow
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Huddersfield, United Kingdom, HD3 3EA
        • Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Hospitals NHS Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, NW1 2PG
        • UCLH, University College London Hospitals
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Newcastle, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospital NHS Trust
      • Oxford, United Kingdom, OX3 7LI
        • Oxford University Hospitals NHS Foundation Trust Churchill Hospital
      • Romford, United Kingdom, RM7 0AG
        • Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Western Park Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospitals NHS Foundation Trust - The Great Western Hospital
      • Taunton, United Kingdom, TA1 5DA
        • Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
      • Walsall, United Kingdom, WS2 9PS
        • Walsall Healthcare NHS Trust - Manor Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust - New Cross Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • California
      • San Francisco, California, United States, 94143
        • University of California San Fransico, Moffitt Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver Anschutz Medical Campus
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Hospital
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Clinical Research Center, Boca Raton Regional Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine, Florida
      • Tampa, Florida, United States, 33612
        • Moffit Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Farmington Hills, Michigan, United States, 48334
        • Wayne State Harper Hospita Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health, Virginia Piper Cancer Institute
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Mallinckrodt Institute of Radiology
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The Ohio State University, Wexner Medical Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Trevose, Pennsylvania, United States, 19053
        • Aria Health
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • St. Marks Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Medical Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Standard of care second-line chemotherapy plus TheraSphere
Device: TheraSphere
yttrium 90 microspheres
No Intervention: Control group
Standard of care second-line chemotherapy with no added therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
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
Progression Free survival by blinded independent central review per RECIST 1.1
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
Hepatic Progression-Free Survival (HPFS)
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.
Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1
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 Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Biocompatibles UK Ltd

Investigators

  • Principal Investigator: Mary F Mulcahy, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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