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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01483027
Recruitment Status : Active, not recruiting
First Posted : December 1, 2011
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Device: TheraSphere Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy
Actual Study Start Date : January 2012
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months ]
  2. Hepatic Progression-Free Survival (HPFS) [ Time Frame: date of randomization until the date of first documented progression in the liver according to RECIST 1.1, or detah. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 completed 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
  • 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 (may resume after Y-90 treatment or immediately if in control arm)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483027


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
University of Alabama
Birmingham, Alabama, United States, 35249
United States, California
University of California San Fransico, Moffitt Hospital
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045
University of Colorado, Denver
Aurora, Colorado, United States, 80045
United States, Delaware
Christiana Care Hospital
Newark, Delaware, United States, 19713
United States, Florida
Lynn Clinical Research Center, Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
University of Miami Miller School of Medicine, Florida
Miami, Florida, United States, 33136
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Carle Clinic
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
University of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State Harper Hospita Karmanos Cancer Institute
Farmington Hills, Michigan, United States, 48334
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Minneapolis
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43210
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Aria Health
Trevose, Pennsylvania, United States, 19053
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8834
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
St. Marks Hospital
Salt Lake City, Utah, United States, 84124
United States, Virginia
Sentara Norfolk General
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
University of Washington
Seattle, Washington, United States, 98195
United States, Wisconsin
Gundersen Medical Foundation
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Aurora Research Institute
Wauwatosa, Wisconsin, United States, 53226
Austria
Medical University of Vienna
Vienna, Austria, 1090
Belgium
Onze-Lieve-Vrouwziekenuis VZW Campus Aalst
Aalst, Belgium, 9300
AZ - Sint Lucas
Gent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
Canada, Nova Scotia
QEII Health Services Center, Halifax Infirmary Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London Regional Cancer program
London, Ontario, Canada, N6A 4L6
University Health Network , Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
McGill University Health Center - Glen Site
Montreal, Quebec, Quebec, Canada, H4A 3J1
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
China
Hong Kong Sanatorium Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
France
CHRU Montpellier - Hopital St Eloi
Montpellier, Cedex 5, France, 34295
CUH d'Angers
Angers, Cedex 9, France, 49933
CHU Toulouse, Hôpital Rangueil
Toulouse, Cedex 9, France, 31059
Institut Bergognié
Bordeaux, France, 33076
Hôpital Henri Mondor
Créteil, France, 94010
Centre Georges Francois Leclerc
Dijon cedex, France, 21000
Hôpital La Timone
Marseille, France, 13005
CHU Nantes-Hôtel Dieu
Nantes, France, 44093
CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2
Nice, France, 6202
CHU Bordeaux
Pessac, France, 33600
Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie
Poitiers, France, 86000
Centre Eugene Marquis
Rennes, France, 35000
Germany
Universitätsklinikum Bonn
Bonn,, Germany, 53127
Universitätsklinikum Essen
Essen, Germany, 45122
Medizinische Hochschule Hannover
Hannover, Germany, 30625
SLK Kliniken, Heilbronn GmbH
Heilbronn, Germany, 74078
University Hospital of Leipzig
Leipzig, Germany, 04103
Eberhard-Karls-University Tübingen
Tübingen, Germany, 72076
Italy
Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
St. Mary's Hospital
Seoul, Korea, Republic of
Poland
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
Warszawa, Poland
Centrum Onkologii - Instytut
Warszawa, Poland
Wojskowy Instytut Medyczny
Warszawa, Poland
Singapore
National University Hospital
Singapore, Singapore, 119228
Spain
Hospital Universitari Vall d'Hebron
Barcelona,, Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 8036
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28220
Hospital Universitario Virgen de la Arrixaca
Murcia,, Spain, 30120
Avenida de Roma, s/n, Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
HCU Lozano Blesa, Planta 11-Oncología-Secretaría
Zaragoza, Spain, 50009
United Kingdom
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
Oxford, England, United Kingdom, OX3 7LI
The Clatterbrdige Cancer Centre NHSF Trust
Bebington, United Kingdom, CH63 4JY
Queen Elizabeth Hospital Cancer Centre
Birmingham, United Kingdom, B15 2TH
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Beatson Cancer Centre and University of Glasgow
Glasgow,, United Kingdom, G12 0YN
University of Glasgow
Glasgow, United Kingdom, G12 0YN
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Leeds Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Royal Liverpool University Hospital
Liverpool,, United Kingdom, L7 8XP
UCLH, University College London Hospitals
London, United Kingdom, NW1 2PG
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom, NE7 7DN
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom, NG5 1PB
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
Oxford, United Kingdom, OX3 7LI
Western Park Hospital
Sheffield, United Kingdom, S10 2SJ
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
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Principal Investigator: Mary F Mulcahy, MD Northwestern University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01483027    
Other Study ID Numbers: TS-102
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases