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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by BTG International Inc.
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01483027
First received: November 24, 2011
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Colorectal Cancer Metastatic
Device: TheraSphere
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: January 2012
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  • Not resected primary tumor; must be clinically stable
  • 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
  • Eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
  • 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
  • Eastern Cooperative Oncology Group (ECOG) of 0-1 through screening to first treatment
  • 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
  • Neutrophil count >1200/cubic mm

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483027

Contacts
Contact: Nathan F Messinger, MSN,RN 912.656.2696 Nathan.Messinger@chiltern.com
Contact: Judith Koehnen +49 (0)221-80068367 judith.Koehnen@Chiltern.com

  Hide Study Locations
Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Curt Johanson    415-353-2310    curt.johanson@cc.ucsf.edu   
Principal Investigator: Nicholas Fidelman, MD         
United States, District of Columbia
George Washington University Hospital Withdrawn
Washington, District of Columbia, United States, 20037
United States, Florida
University of Miami Miller School of Medicine, Florida Recruiting
Miami, Florida, United States, 33136
Contact: Doris Martin    305-243-5491    dmartin3@med.miami.edu   
Principal Investigator: Lorraine Portelance, MD         
Moffit Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Malesa Pereira    813-745-4090    malesa.pereira@moffitt.org   
Principal Investigator: Nishi Kothari, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlene del Castillo    312-695-1518    carlene.castillo@northwestern.edu   
Principal Investigator: Mary Mulcahy, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Ashley Roche    312-563-2169    ashley_roche@rush.edu   
Principal Investigator: Marisa Hill, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Tamiko MaGee    317-278-7557    trmagee@iupui.edu   
Principal Investigator: Matthew S Johnson, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Schlegel    502-629-3383    melissa.schlegel@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
United States, Maryland
The Johns Hopkins Hospital Withdrawn
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lahey Clinic - Tufts University Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Nanette Matrullo, MD    781-744-4290    nanette.matrullo@lahey.org   
Principal Investigator: Shams Iqbal, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Debra Krease    734-764-6847    debraakr@med.umich.edu   
Principal Investigator: Mary Feng, MD         
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Colette Zack    313-576-9385    zackc@karmanos.org   
Principal Investigator: Phillip Phillip, MD         
Saint Mary's Healthcare Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathy Estkowski    616-685-5156    estkowk@mercyhealth.com   
Principal Investigator: Matthew A Tiede, MD         
Spectrum Health / Advanced Radiology Services Recruiting
Grand Rapids, Michigan, United States, 49506
Contact: Kimberly Mohr, BSN,RN,CCRC    616-486-6111    kimberly.mohr@spectrumhealth.org   
Principal Investigator: Manish Varma, MD         
United States, Minnesota
Virginia Piper Cancer Institute, Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Lisa Albers    612-863-9466    lisa.albers@allina.com   
Principal Investigator: Joseph Leach, MD         
Mayo Clinic Withdrawn
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Robin Haverman    314-747-1624    havermanr@wustl.edu   
Principal Investigator: Darryl Zuckerman, MD         
United States, New York
University of Rochester, James P Wilmot Cancer Ctr Recruiting
Rochester, New York, United States, 14642
Contact: Laurie Koek    585-275-8213    Laurie_koek@urmc.rochester.edu   
Principal Investigator: Marcus Noel, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ihab Haddadin, MD    216-444-0405    haddadi@ccf.org   
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clare Lane    216-445-9380    lanec@ccf.org   
Principal Investigator: Haddadin Ihab, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Saba Elias       saba.elias@osumc.edu   
Principal Investigator: Hooman Khabiri, MD         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Kimberly Garrett    937-208-3307    kjgarrett@PremierHealth.com   
Principal Investigator: Shannon Kauffman, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Evelyn Stainthorpe, BS, CCRC    212-662-6983    evelyn.stainthorpe@uphs.upenn.edu   
Principal Investigator: Michael C Soulen, MD         
Diagnostic Imaging Inc Recruiting
Trevose, Pennsylvania, United States, 19053
Contact: Sally Wagenborg, RN, CCRP    215-612-4881    swagenborg@ariahealth.org   
Principal Investigator: Aaron Shiloh, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Christina Carrigan    214-645-2704    christina.carrigan@utsouthwestern.edu   
Principal Investigator: Anil Pillai, MD         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia Brown    713-792-2924    cbrown@mdanderson.org   
Principal Investigator: Armeen Mahvash, MD         
United States, Utah
St. Marks Hospital Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Melinda Turpin    801-831-0512    melinda.turpin@mountainstarhealth.com   
Principal Investigator: James Carlisle, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Royanne Koogler    434-924-9496    RLB8Y@virginia.edu   
Contact: Snjezana Zaja-Milatovic    434-243-6575    SZ7S@virginia.edu   
Principal Investigator: James Stone, MD         
Sentara Cancer Research Recruiting
Norfolk, Virginia, United States, 23507
Contact: Angela Bowman    757-388-1926    ambowman@sentara.com   
Principal Investigator: Harlan Vingan, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Stephanie DiGiacomo    206-288-6358    sdigiaco@seattlecca.org   
Principal Investigator: Siddharth Padia, MD         
Principal Investigator: William P Harris, MD         
United States, Wisconsin
Gundersen Medical Foundation Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Caryleigh Caryleigh    608-775-0852    cmrasmus@gundersenhealth.org   
Principal Investigator: Azene Ezana, MD         
University of Wisconsin Hospital & Clinics Withdrawn
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin, Inc. Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Elizabeth Weil    414-805-3028    eweil@mcw.edu   
Principal Investigator: William Rilling, MD         
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1210
Contact: Johanna Moyes    0043-1-40 400-58900    johanna.moyses@akhwien.at   
Principal Investigator: Christian Loewe, MD         
Belgium
AZ - Sint Lucas Ziekemhuis Recruiting
Gent, Oost-Vlaander, Belgium, 9000
Contact: Joline Goossens    0032 9 224 6227    Joline.Goossens@AZSTLUCAS.BE   
Principal Investigator: Johan Van Ongeval, MD         
VZW AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Fien Verplancke    0032 566 33337    fien.verplancke@azgroeninge.be   
Principal Investigator: Philippe Vergauwe, MD         
Canada, Nova Scotia
QEII Health Services Center Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Lorrie Yunace    902-473-6105    lorrie.yunace@nshealth.ca   
Principal Investigator: Robert Abraham, MD         
Canada, Ontario
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Anne Malpage    519-685-8618    anne.malpage@lhsc.on.ca   
Principal Investigator: Stephen Welch, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Cheryl Geen-Smith    (416) 946-4501 ext 6639    cheryl.geen-smith@uhn.ca   
Principal Investigator: John Beecroft, MD         
Canada, Quebec
McGill University Health Centre / Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Ayat Salman    (514) 934-1934 ext 36237    Ayat.Salman@MUHC.MCGILL.CA   
Principal Investigator: Tatiana Cabrera, MD         
China
Hong Kong Sanatorium and Hospital Recruiting
Hong Kong, China
Contact: Janet Leung    852-2835-8877    janet.ky.leung@hksh.com   
Principal Investigator: Thomas Leung, MD         
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Carolyn Heung    852-2255-4216    heungkl@hku.hk   
Principal Investigator: Victor Lee, MD         
Czech Republic
Clinici of Imaging Methods - University Hospital Plzen Withdrawn
Plzen, Czech Republic, 30640
France
CHRU Montpellier - Hopital St Eloi - imagerie medical Recruiting
Montpellier, Cedex 5, France, 34295
Contact: Chloe Guillot    0033 4 67 33 73 27    chloe-guillot@chu-montpellier.fr   
Principal Investigator: Boris Guiu, MD         
CHU d'Angers, Gastroenterologie, Endoscopie & Oncologie digestive Médecine Recruiting
Angers, Cedex 9, France, 49933
Contact: François-Xavier Caroli-Bosc    0033 2 41 35 59 17    FXCaroli-Bosc@chu-angers.fr   
Principal Investigator: François-Xavier Caroli-Bosc, MD         
CHU Toulouse, Hôpital Rangueil Recruiting
Toulouse, Cedex 9, France, 31059
Contact: Caroline Gregoire    0033 5 61322188    gregoire.c@chu-toulouse.fr   
Principal Investigator: Rosine Guimbaud, MD         
Hôpital Henri Mondor, Oncologie médical Recruiting
Créteil, France, 94010
Contact: Julia Francese    0033 1 49 81 41 64    julia.francese@hmn.aphp.fr   
Principal Investigator: Christophe Tournigand, MD         
Hotel-Dieu, Service d'Hepatogastro-enterologie Recruiting
Nantes, France, 44093
Contact: Helene Auble    0033 2 40 08 75 03    Helene.AUBLE@chu-nantes.fr   
Principal Investigator: Yann Touchefeu, MD         
CHU de Nice, Hôpital de l'Archet, Radiology Recruiting
Nice, France, 6202
Contact: Sylvie Viano       Viano.s@chu-nice.fr   
Principal Investigator: Patrick Chevallier, MD         
Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie Recruiting
Poitiers, France, 86000
Contact: Laetitia Rouleau    0033 54 9443413    laetitia.rouleau@chu-poitiers.fr   
Principal Investigator: David Tougeron, MD         
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Gaelle Kergoat    33 299 25 32 61    g.kergoat@rennes.unicancer.fr   
Principal Investigator: Marc Pracht, MD         
Italy
Universitaria di Bologna Recruiting
Bologna, Italy, 40138
Principal Investigator: Rita Golfieri, MD         
Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: JU-EUN LEE    82-2-2019-3724    eigenpostll@naver.com   
Principal Investigator: Kwang-Hun Lee, MD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Hee Nam    82-2-920-6082    kumccrc@gmail.com   
Principal Investigator: Yeul Hong Kim, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yuri Ko    82-2-2072-7611    gosima0225@naver.com   
Principal Investigator: Tae-You Kim, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: TAE IL KIM    82-2-2228-1965    TAEILKIM@yuhs.ac   
Principal Investigator: TAE IL KIM, MD         
St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun-joo Ahn    82-2-2258-6804    susang2903@hanmail.net   
Principal Investigator: Myung Ah Lee, MD         
Singapore
National University Hospital Singapore Recruiting
Singapore, Singapore, 119228
Contact: Patrick Marban       csimpc@nus.edu.sg   
Principal Investigator: Thomas Soh, MD         
National University Hospital Recruiting
Singapore, Singapore
Contact: Partick Marban       csimpc@nus.edu.sg   
Principal Investigator: Thomas Soh Peng, MD         
Spain
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28220
Contact: Rocio Navarro    0034 911 917 418    rocio.navarro@salud.madrid.org   
Principal Investigator: Ana Ruiz Casado, MD         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Cristina Carrera       cristina.carrera.hryc@gmail.com   
Principal Investigator: Carmen Guillen Ponce, MD         
University Hospital "Fundacion Jimenez Diaz" Recruiting
Madrid, Spain, 28040
Contact: Margarita Lobo    34 915 504 800 ext 2299    mlobo@fjd.es   
Principal Investigator: Ana Leon, MD         
Hospital General Universitario Gregorio Maronon Recruiting
Mardid, Spain, 28007
Contact: Ana Corcuera Sánchez    914 269 394    acorcuera.hgugm@gmail.com   
Principal Investigator: Pilar-Garcia Alfonso, MD         
Hospital Universitaario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact: Jose-Maria Vieitez    0034 985 106 100    josemariavieitez@yahoo.es   
Principal Investigator: Jose-Maria Vieitez, MD         
Hospital Clínico Lozano Blesa, Zaragoza Recruiting
Zaragoza, Spain, 50009
Contact: Maria-Pilar Emperador-Escudero    0034 976 76 57 46    pescudero@salud.aragon.es   
Principal Investigator: Maria-Pilar Emperador-Escudero, MD         
United Kingdom
Churchill Hospital Recruiting
Oxford, England, United Kingdom, OX3 7LE
Contact: Anju Chalin    0044 1865 235309    trialadministrator07@oncology.ox.ac.uk   
Principal Investigator: Ricky Sharma         
Edinburgh Cancer Centre - Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Moira Stewart    0131 537 2201    moira.stewart11@ed.ac.uk   
Principal Investigator: Ewan Brown, MD         
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Contact: Ceri Jamieson    0148 340 66 12    cerijamieson@nhs.net   
Principal Investigator: Tony Dhillon, MD         
University College London Hospitals Foundation NHS Trust Recruiting
London, United Kingdom, NW1 2BU
Contact: Christopher Wanstall    020 344 75103    Christopher.Wanstall@uclh.nhs.uk   
Principal Investigator: Steve Bandula, MD         
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Lorna Caplis    020 7188 8718    loma.caplis@gstt.nhs.uk   
Principal Investigator: Paul Ross, MD         
The Christie, Manchester Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Julie Royle    0161 446 8344    julie.royle@christie.nhs.uk   
Principal Investigator: Gregory Wilson, MD         
The Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Jonathan Stoddart    0191 213 8439    Jonathan.Stoddart@nuth.nhs.uk   
Principal Investigator: Ashraf Azzabi, MD         
Nottingham University Hospital NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Jackie Worville    0115 969 1169 ext 54692    jackie.worville@nuh.nhs.uk   
Principal Investigator: Jamie Mills, MD         
Western Park Hospital - Sheffield Teaching Hospitals Trial Center Recruiting
Sheffield, United Kingdom, NW3 2QG
Contact: Alison Redfearn    0044 114 226 51 60    a.redfearn@sheffield.ac.uk   
Principal Investigator: Joanne Hornbuckle, MD         
University Hospital Southampton, Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Davis Liane    023 81 208448    L.Davis@soton.ac.uk   
Principal Investigator: Andrew Bateman, MD         
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Mary F Mulcahy, MD Northwestern University
Principal Investigator: Ricky Sharma, MA FRCP FRCR PhD University of Oxford
  More Information

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01483027     History of Changes
Other Study ID Numbers: TS-102 
Study First Received: November 24, 2011
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 25, 2016