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Colorectal Cancer MetastaticEPOCHNCT01483027

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

A study testing TheraSphere in people with Colorectal Cancer Metastatic, run by Boston Scientific Corporation at 131 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
TheraSphere
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
131 sitesin 13 countries
Study dates
Jan 2012to 31 Aug 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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)

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

131 sites in 13 countries.

131 sites in 13 countries

United States35 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • University of Colorado Denver Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Lynn Clinical Research Center, Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Wayne State Harper Hospita Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Gundersen Medical Foundation

    La Crosse, Wisconsin, 54601

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Miami Miller School of Medicine, Florida

    Miami, Florida, 33136

  • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Allina Health, Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Minneapolis

    Minneapolis, Minnesota, 55407

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Hospital

    Newark, Delaware, 19713

  • Sentara Norfolk General

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Beaumont Hospital

    Royal Oak, Michigan, 48073

  • St. Marks Hospital

    Salt Lake City, Utah, 84124

  • University of California San Fransico, Moffitt Hospital

    San Francisco, California, 94143

  • University of Washington

    Seattle, Washington, 98195

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110

  • Moffit Cancer Center

    Tampa, Florida, 33612

  • Aria Health

    Trevose, Pennsylvania, 19053

  • Carle Clinic

    Urbana, Illinois, 61801

  • Aurora Research Institute

    Wauwatosa, Wisconsin, 53226

Other trials in United States

United Kingdom27 sites

  • NHS Grampian - Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Royal United Hospital Bath NHS Trust

    Bath, BA1 3NG

  • The Clatterbrdige Cancer Centre NHSF Trust

    Bebington, CH63 4JY

  • Queen Elizabeth Hospital Cancer Centre

    Birmingham, B15 2TH

  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson Cancer Centre and University of Glasgow

    Glasgow, G12 0YN

  • University of Glasgow

    Glasgow, G12 0YN

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Leeds Hospitals NHS Trust

    Leeds, LS9 7TF

  • UCLH, University College London Hospitals

    London, NW1 2PG

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE7 7DN

  • Nottingham University Hospital NHS Trust

    Nottingham, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust Churchill Hospital

    Oxford, OX3 7LI

  • Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital

    Romford, RM7 0AG

  • Western Park Hospital

    Sheffield, S10 2SJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Great Western Hospitals NHS Foundation Trust - The Great Western Hospital

    Swindon, SN3 6BB

  • Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital

    Taunton, TA1 5DA

  • Walsall Healthcare NHS Trust - Manor Hospital

    Walsall, WS2 9PS

  • The Royal Wolverhampton NHS Trust - New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Spain18 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario del Henares

    Coslada, 28822

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, 28942

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Madrid, 28220

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29010

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Avenida de Roma, s/n, Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Parc Taulí Sabadell Hospital Universitari

    Sabadell, 8208

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • HCU Lozano Blesa, Planta 11-Oncología-Secretaría

    Zaragoza, 50009

Other trials in Spain

France14 sites

  • CUH d'Angers

    Angers, Cedex 9, 49933

  • Institut Bergognié

    Bordeaux, 33076

  • Hôpital Beaujon

    Clichy, 92110

  • Hôpital Henri Mondor

    Créteil, 94010

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • Centre Hospitalier Lyon-Sud

    Lyon, 69003

  • Hôpital La Timone

    Marseille, 13005

  • CHRU Montpellier - Hopital St Eloi

    Montpellier, Cedex 5, 34295

  • CHU Nantes-Hôtel Dieu

    Nantes, 44093

  • CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2

    Nice, 6202

  • CHU Bordeaux

    Pessac, 33600

  • Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie

    Poitiers, 86000

  • Centre Eugene Marquis

    Rennes, 35000

  • CHU Toulouse, Hôpital Rangueil

    Toulouse, Cedex 9, 31059

Other trials in France

Germany8 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Essen

    Essen, 45122

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK Kliniken, Heilbronn GmbH

    Heilbronn, 74078

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • University Hospital of Leipzig

    Leipzig, 04103

  • Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie

    Marburg, 35043

  • Eberhard-Karls-University Tübingen

    Tübingen, 72076

Other trials in Germany

Poland8 sites

  • Białostockie Centrum Onkologii

    Bialystok

  • Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie

    Gliwice

  • Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego

    Grudziądz

  • Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.

    Lublin

  • Szpital Kliniczny im. Heliodora Święcickiego

    Poznan

  • Centralny Szpital Kliniczny MSWiA

    Warsaw

  • Centrum Onkologii - Instytut

    Warsaw

  • Wojskowy Instytut Medyczny

    Warsaw

Other trials in Poland

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • QEII Health Services Center, Halifax Infirmary Site

    Halifax, Nova Scotia, B3H 3A7

  • London Regional Cancer program

    London, Ontario, N6A 4L6

  • McGill University Health Center - Glen Site

    Montreal, Quebec, Quebec, H4A 3J1

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network , Mount Sinai Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

South Korea5 sites

  • Gangnam Severance Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

  • St. Mary's Hospital

    Seoul

Other trials in South Korea

Belgium4 sites

  • Onze-Lieve-Vrouwziekenuis VZW Campus Aalst

    Aalst, 9300

  • AZ - Sint Lucas

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

Other trials in Belgium

China2 sites

  • Hong Kong Sanatorium Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in China

Austria1 site

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Italy1 site

  • Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi

    Bologna, 40138

Other trials in Italy

Singapore1 site

  • National University Hospital

    Singapore, 119228

Other trials in Singapore

About this study

Official title: 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.

Being tested
TheraSphere

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TheraSphereDevice

    yttrium 90 microspheres

Study groups in NCT01483027
Study groupRoleWhat they receive
Treatment groupExperimentalStandard of care second-line chemotherapy plus TheraSphere
Receives: Device: TheraSphere
Control groupNo interventionStandard of care second-line chemotherapy with no added therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression Free survival by blinded independent central review per RECIST 1.1

    Measured: 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

  2. Hepatic Progression-Free Survival (HPFS)

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

    Measured: 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 outcomes (1)

  1. Overall Survival

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01483027
Sponsor's protocol ID
TS-102
Acronym
EPOCH
Status last verified
Mar 2022
First submitted
24 Nov 2011
Last updated
29 Mar 2022
Data monitoring committee
Yes

Publications

  • Lam M, Kersting D, Harris W, Boucher E, Garin E, Fowers K, Salem R. Post-hoc analysis of adverse events during the EPOCH trial: reconsidering dosimetry. Eur J Nucl Med Mol Imaging. 2026 Aug;53(10):5994-5998. doi: 10.1007/s00259-026-07948-6. Epub 2026 May 29.

    PubMed 42209817

  • Salem R, Garin E, Boucher E, Fowers K, Lam M, Padia S, Harris W. Optimal patient selection for yttrium-90 glass plus chemotherapy in the treatment of colorectal liver metastases: additional quality of life, efficacy, and safety analyses from the EPOCH study. Oncologist. 2024 Aug 5;29(8):681-689. doi: 10.1093/oncolo/oyae128.

    PubMed 38985849

  • 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.

    PubMed 34541864

  • 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.

    PubMed 30664496

Questions about this trial

What is this clinical trial studying?

A study testing TheraSphere in people with Colorectal Cancer Metastatic, run by Boston Scientific Corporation at 131 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, United Kingdom, Spain, France, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01483027, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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