Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer
NCT ID: NCT01483027
Last Updated: 2022-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
428 participants
INTERVENTIONAL
2012-01-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
Standard of care second-line chemotherapy plus TheraSphere
TheraSphere
yttrium 90 microspheres
Control group
Standard of care second-line chemotherapy with no added therapy
No interventions assigned to this group
Interventions
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TheraSphere
yttrium 90 microspheres
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biocompatibles UK Ltd
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mary F Mulcahy, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Fransico, Moffitt Hospital
San Francisco, California, United States
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States
Christiana Care Hospital
Newark, Delaware, United States
Lynn Clinical Research Center, Boca Raton Regional Hospital
Boca Raton, Florida, United States
University of Miami Miller School of Medicine, Florida
Miami, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle Clinic
Urbana, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Wayne State Harper Hospita Karmanos Cancer Institute
Farmington Hills, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Aria Health
Trevose, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
St. Marks Hospital
Salt Lake City, Utah, United States
Sentara Norfolk General
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Gundersen Medical Foundation
La Crosse, Wisconsin, United States
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Aurora Research Institute
Wauwatosa, Wisconsin, United States
Medical University of Vienna
Vienna, , Austria
Onze-Lieve-Vrouwziekenuis VZW Campus Aalst
Aalst, , Belgium
AZ - Sint Lucas
Ghent, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
QEII Health Services Center, Halifax Infirmary Site
Halifax, Nova Scotia, Canada
London Regional Cancer program
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network , Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Center - Glen Site
Montreal, Quebec, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Hong Kong Sanatorium Hospital
Hong Kong, , China
Queen Mary Hospital
Hong Kong, , China
CHRU Montpellier - Hopital St Eloi
Montpellier, Cedex 5, France
CUH d'Angers
Angers, Cedex 9, France
CHU Toulouse, Hôpital Rangueil
Toulouse, Cedex 9, France
Institut Bergognié
Bordeaux, , France
Hôpital Beaujon
Clichy, , France
Hôpital Henri Mondor
Créteil, , France
Centre Georges Francois Leclerc
Dijon, , France
Centre Hospitalier Lyon-Sud
Lyon, , France
Hôpital La Timone
Marseille, , France
CHU Nantes-Hôtel Dieu
Nantes, , France
CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2
Nice, , France
CHU Bordeaux
Pessac, , France
Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie
Poitiers, , France
Centre Eugene Marquis
Rennes, , France
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Essen
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
SLK Kliniken, Heilbronn GmbH
Heilbronn, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
University Hospital of Leipzig
Leipzig, , Germany
Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie
Marburg, , Germany
Eberhard-Karls-University Tübingen
Tübingen, , Germany
Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Białostockie Centrum Onkologii
Bialystok, , Poland
Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie
Gliwice, , Poland
Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego
Grudziądz, , Poland
Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.
Lublin, , Poland
Szpital Kliniczny im. Heliodora Święcickiego
Poznan, , Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, , Poland
Centrum Onkologii - Instytut
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
National University Hospital
Singapore, , Singapore
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
St. Mary's Hospital
Seoul, , South Korea
Hospital Universitario Fundación Alcorcón
Alcorcón, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario del Henares
Coslada, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Regional Universitario de Málaga - Hospital General
Málaga, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Avenida de Roma, s/n, Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Parc Taulí Sabadell Hospital Universitari
Sabadell, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
HCU Lozano Blesa, Planta 11-Oncología-Secretaría
Zaragoza, , Spain
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Royal United Hospital Bath NHS Trust
Bath, , United Kingdom
The Clatterbrdige Cancer Centre NHSF Trust
Bebington, , United Kingdom
Queen Elizabeth Hospital Cancer Centre
Birmingham, , United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
Bournemouth, , United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Beatson Cancer Centre and University of Glasgow
Glasgow, , United Kingdom
University of Glasgow
Glasgow, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
Leeds Hospitals NHS Trust
Leeds, , United Kingdom
UCLH, University College London Hospitals
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
Oxford, , United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital
Romford, , United Kingdom
Western Park Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Great Western Hospitals NHS Foundation Trust - The Great Western Hospital
Swindon, , United Kingdom
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
Taunton, , United Kingdom
Walsall Healthcare NHS Trust - Manor Hospital
Walsall, , United Kingdom
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TS-102
Identifier Type: -
Identifier Source: org_study_id
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