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

This study is currently recruiting participants.
Verified August 2017 by BTG International Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483027
First Posted: December 1, 2011
Last Update Posted: September 1, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.
  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
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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • 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
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


Contacts
Contact: John Saliba +79 81 881 6336 John.Saliba@chiltern.com
Contact: Judith Koehnen +49 (0)221-80068367 judith.Koehnen@Chiltern.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: April Riddle    205-934-6504    ariddle@uabmc.edu   
Principal Investigator: Ahmed Abdel Aal Kamel         
University of Alabama Recruiting
Birmingham, Alabama, United States, 35249
Contact: April Riddle    205-934-6504    "ariddle@uabmc.edu   
Principal Investigator: Ahmed Abdel Aal Kamel         
United States, California
University of California San Fransico, Moffitt Hospital Recruiting
San Francisco, California, United States, 94143
Contact: Curt Johanson    415-353-2310    curt.johanson@cc.ucsf.edu   
Principal Investigator: Nicholas Fidelman, MD         
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Hilary Vannoort    720-848-6618    hilary.vannoort@ucdenver.edu   
Principal Investigator: Thor Johnson         
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Hilary van Noort    720-848-6618    "hilary.vannoort@ucdenver.edu   
Principal Investigator: Thor Johnson         
United States, Delaware
Christiana Care Hospital Recruiting
Newark, Delaware, United States, 19713
Contact: Carla Bruegel    302-623-4453    "CBruegel@christianacare.org   
Principal Investigator: Michael Guarino         
United States, District of Columbia
George Washington University Hospital Withdrawn
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
Lynn Clinical Research Center, Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Sylvie Godbout    561-955-4539    sgodbout@brrh.com   
Principal Investigator: George Khoriaty         
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@gmail.com   
Principal Investigator: Nishi Kothari, MD         
United States, Illinois
Northwestern University 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
Principal Investigator: Marisa Hill, MD         
Carle Clinic Recruiting
Urbana, Illinois, United States, 61801
Contact: Clarissa Carter         
Principal Investigator: Kendrith Rowland         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sarah Munson    317-963-0305    sed@iu.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 Withdrawn
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Debra Krease    734-764-6847    debraakr@med.umich.edu   
Principal Investigator: Kyle Cuneo,, MD         
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Debra Krease    734-764-6847    debraakr@med.umich.edu   
Principal Investigator: Kyle Cuneo         
Wayne State Harper Hospita Karmanos Cancer Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Colette Zack    313-576-9385    zackc@karmanos.org   
Principal Investigator: Phillip Phillip, MD         
Saint Mary's Healthcare Withdrawn
Grand Rapids, Michigan, United States, 49503
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Mollie Lockard, BSN,RN,CCRC    616-486-6111    Mollie.Lockard@spectrumhealth.org   
Principal Investigator: Manish Varma, MD         
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Catherine Thoman    248-551-7029    "catherine.thoman@beaumont.org   
Principal Investigator: Michael Savin         
United States, Minnesota
Allina Health, Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kelsey kelsey.froemming@allina.com    612-863-8551    jacquelyn.underhill@allina.com   
Principal Investigator: Samith Kochuparambil, MD         
Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Laura Rockwell    612-863-9466    Laura.rockwell@allina.com   
Principal Investigator: Samith Kochuparambil         
Mayo Clinic Withdrawn
Rochester, Minnesota, United States, 55905
United States, Missouri
Mallinckrodt Institute of Radiology Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robin Haverman:    314-747-1624    rlhaverman@wustl.edu   
Principal Investigator: Darryl Zuckerman, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christina Zenobi    646-888-1350    "zenobic@mskcc.org   
Principal Investigator: Constantinos Sofocleous         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kari Steinmetz    585-275-1599    Kari_Steinmetz@urmc.rochester.edu   
Principal Investigator: Marcus Noel, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clare Lane, MD    216-445-9380    lanec@ccf.org   
Principal Investigator: Ihab Haddadin         
The Ohio State University, Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Hooman Khabiri, MD         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Teresa Evanoff    937-208-3307    Teresa.evanoff@wright.edu   
Principal Investigator: Shannon Kauffman, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristi Lelionis    215-746-6788    Kristi.Lelionis@uphs.upenn.edu   
Principal Investigator: Michael C Soulen, MD         
Aria Health 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 at Dallas Recruiting
Dallas, Texas, United States, 75390-8834
Contact: Ayobami Odu    214-645-2704    christina.carrigan@utsouthwestern.edu   
Principal Investigator: Patrick Sutphin         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ayobami Odu    214-590-1310    ayobami.odu@utsouthwestern.edu   
Principal Investigator: Patrick Sutphin, MD         
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kathryn Moss    713-792-5951    kemoss@mdanderson.org   
Principal Investigator: Armeen Mahvash, MD         
United States, Utah
St. Marks Hospital Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Melinda Turpin    801-268-7102    melinda.turpin@mountainstarhealth.com   
Principal Investigator: James Carlisle, MD         
United States, Virginia
University of Virginia Health System Withdrawn
Charlottesville, Virginia, United States, 22908
Sentara Norfolk General Recruiting
Norfolk, Virginia, United States, 23507
Contact: Denitra Mack    757-388-5224    dsbrooks@sentara.com   
Principal Investigator: Harlan Vingan, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Jonathan Khanjian    206-288-2004    meros@seattlecca.org, erosm@uw.edu   
Principal Investigator: Siddarth Padia         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Stephanie DiGiacomo    206-288-6358    sdigiaco@seattlecca.org   
Principal Investigator: Guy Johnson, MD         
Principal Investigator: William P Harris, MD         
United States, Wisconsin
Gundersen Medical Foundation Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Cindy Murphy    608-775-6782    camurphy@gundersenhealth.org   
Principal Investigator: Azene Ezana, MD         
University of Wisconsin Hospital & Clinics Withdrawn
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Elizabeth Weil    414-805-2077    eweil@mcw.edu   
Principal Investigator: William Rilling, MD         
Aurora Research Institute Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Kimberly Schlinder         
Principal Investigator: Steven Huffman         
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Johanna Moyes    0043-1-40 400-58900    johanna.moyses@akhwien.at   
Principal Investigator: Loewe Christian, MD         
Belgium
Onze-Lieve-Vrouwziekenuis VZW Campus Aalst Recruiting
Aalst, Belgium, 9300
Contact: Ilse Claessens    +32 53 72 45 02    "Ilse.claessens@olvz-aalst.be   
Principal Investigator: Koen Hendrickx         
AZ - Sint Lucas Recruiting
Gent, Belgium, 9000
Contact: Sophie Claeys    3292245170    sophie.claeys@azstlucas.be   
Principal Investigator: Johan Van Ongeval, MD         
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Fien Verplancke    0032 566 33338    fien.verplancke@azgroeninge.be   
Principal Investigator: Philippe Vergauwe, MD         
Canada, Nova Scotia
QEII Health Services Center, Halifax Infirmary Site Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Lorrie Yunace    902-473-6105    lorrie.yunace@nshealth.ca   
Principal Investigator: Robert Berry, MD         
Canada, Ontario
London Regional Cancer program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Anne Malpage    519-685-8618    anne.malpage@lhsc.on.ca   
Principal Investigator: Stephen Welch, MD         
University Health Network , Mount Sinai Hospital Recruiting
Toronto, Ontario, Ontario, Canada, M5G 2C4
Contact: Iris Zhong    416-946-4501 ext 6639    iris.zhong@uhn.ca   
Principal Investigator: Robert Beecroft, MD         
Canada, Quebec
McGill University Health Center - Glen Site Recruiting
Montreal, Quebec, Quebec, Canada, H4A 3J1
Contact: Ayat Salman    514-934-1934 ext 36995    Ayat.Salman@MUHC.MCGILL.CA   
Principal Investigator: Tatiana Cabrera, MD         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Saskatchewan, Canada, S7N 0W8
Contact: Adeola Adesokan    (306) 978-8306    adeola.adesokan@usask.ca   
Principal Investigator: Kiat (Jon) Tsong Tan         
Canada
Royal University Hospital Recruiting
Saskatchewan, Canada, S7N 0W8
Contact: Helga Halfinger    306-321-7999    "helga.halfinger@usask.ca   
Principal Investigator: Kiat (Jon) Tsong Tan         
China
Hong Kong Sanatorium Hospital Recruiting
Hong Kong, China
Contact: KIT Ying Leung    852-2835-8877    janet.ky.leung@hksh.com   
Principal Investigator: Thomas Leung, MD         
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Michelle Li    852-2255-5124    drliyun@hku.hk   
Principal Investigator: Victor Lee, MD         
Czechia
Clinici of Imaging Methods - University Hospital Plzen Withdrawn
Plzen, Czechia, 30640
France
CHRU Montpellier - Hopital St Eloi Recruiting
Montpellier, Cedex 5, France, 34295
Contact: Leslie Bouisset    0033 467 33 93 77    I-bouisset@chu-montpellier.fr   
Principal Investigator: Boris Guiu, MD         
CUH d'Angers Recruiting
Angers, Cedex 9, France, 49933
Contact: Nathanaelle Cornet    0033241356054    nathanaelle.cornet@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         
Institut Bergognié Recruiting
Bordeaux, France, 33076
Contact: Laurence Virmoux    +33 5 56 33 33 33 3531    "l.virmoux@bordeaux.unicancer.fr   
Principal Investigator: Jean Palussiere         
Hôpital Henri Mondor Recruiting
Créteil, France, 94010
Contact: Amina Bouras    14517824385    amina.bouras@aphp.fr   
Principal Investigator: Christophe Tournigand, MD         
Centre Georges Francois Leclerc Recruiting
Dijon cedex, France, 21000
Contact: Sophie Debard    +33 3 80 73 77 51    sdebard@cgfl.fr   
Principal Investigator: Francois Ghiringhelli         
Hôpital La Timone Recruiting
Marseille, France, 13005
Contact: Mlle Louise Quelennec    +33 4 91 38 84 72    louise.quelennec@ap-hm.fr   
Principal Investigator: Jean-François Seitz         
CHU Nantes-Hôtel Dieu 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,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2 Recruiting
Nice, France, 6202
Contact: Emmanuelle Mouraux    +33 4 92 03 94 06    mouraux.e@chu-nice.fr   
Principal Investigator: Patrick Chevallier, MD         
CHU Bordeaux Recruiting
Pessac, France, 33600
Contact: Ana Mustel    +33 5 57 62 34 68    ana.mustel@chu-bordeaux.fr   
Principal Investigator: Eric Terrebonne         
Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie Recruiting
Poitiers, France, 86000
Contact: Laetitia Rouleau    003354 9443044    laetitia.rouleau@chu-poitiers.fr   
Principal Investigator: David Tougeron, MD         
Centre Eugene Marquis Recruiting
Rennes, France, 35000
Contact: Gaelle Kergoat    33 299 25 32 61    g.kergoat@rennes.unicancer.fr   
Principal Investigator: Marc Pracht, MD         
Germany
Universitätsklinikum Bonn Recruiting
Bonn,, Germany, 53127
Contact: Annabelle Vogt    +49 228 287 51413/51412    "annabelle.vogt@ukb.uni-bonn.de   
Principal Investigator: Christian Strassburg         
Universitätsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Gabriele Linden    0049 0201 723 85756    Gabriele.Linden@uk-essen.de   
Principal Investigator: Andreas Bockisch         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Hannelore Birkner-Kreutz    0049 511 532 6779    Birkner-Kreutz.Hannelore@mh-hannover.de   
Principal Investigator: Arndt Vogel         
SLK Kliniken, Heilbronn GmbH Recruiting
Heilbronn, Germany, 74078
Contact: Katja Henninger    0049 7131 49 2807    katja.henninger01@slk-kliniken.de   
Principal Investigator: Uwe Martens         
University Hospital of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Elfi Boxhammer    0049 341 97 16997    elfi.boxhammer@medizin.uni-leipzig.de   
Principal Investigator: Michael Moche         
Eberhard-Karls-University Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Petra Engels    0049 7071 2985836    "Petra.Engels@med.uni-tuebingen.de   
Principal Investigator: Helmut Dittmann         
Italy
Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy, 40138
Contact: Elena Scandellari    +39 051 214 2647    ; elena.scandellari@aosp.bo.it   
Principal Investigator: Rita Golfieri, MD         
Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-Moon Joo    82-10-2743-0922    HUCHI79@yuhs.ac   
Principal Investigator: Lee Kwang-Hun, MD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun Jin Park    82-2-920-6444    hioooih@naver.com   
Principal Investigator: Yeul Hong Kim, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yuri Ko    82-10-3465-4369    gosima0225@naver.com   
Principal Investigator: Tae-You Kim, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Se Hee Yoon    82-10-2815-1057    ysh1057@yuhs.ac   
Principal Investigator: TAE IL KIM, MD         
St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun-joo Ahn    82-10-9353-2903    susang2903@hanmail.net   
Principal Investigator: Myung Ah Lee, MD         
Poland
Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie Recruiting
Gliwice, Poland
Contact: Barbara Bobek-Billewicz    32 278 82 07    sekretariat@io.gliwice.pl   
Principal Investigator: Barbara Bobek-Billewicz         
Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego Recruiting
Grudziądz, Poland
Contact: Katarzyna Katarzyna    I32: 48 56 641 40 79    wojwolff@wp.pl   
Principal Investigator: Wojciech Adam Wolff         
Centralny Szpital Kliniczny MSWiA Recruiting
Warszawa, Poland
Contact: Marta Lubinska    48 514 234 091    marta.lubinska@cskmswia.pl   
Principal Investigator: Andrzej Deptała         
Centrum Onkologii - Instytut Recruiting
Warszawa, Poland
Contact: Dawid Prószyński    +48 668 391 391    dproszynski@gmail.com   
Principal Investigator: Lucjan Wyrwicz         
Centrum Onkologii - Instytut Recruiting
Warszawa, Poland
Contact: Agnieszka Ćwikła    +48 601 359 657    sekretariat_waw@coi.pl   
Principal Investigator: Agnieszka Kolasińska-Ćwikła         
Wojskowy Instytut Medyczny Recruiting
Warszawa, Poland
Contact: Cezary Szczylik    48 22 618 72 35    cszczylik@wim.mil.pl   
Principal Investigator: Prof. Cezary Szczylik         
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Patrick Marban       csimpc@nus.edu.sg   
Principal Investigator: Wei Peng Young, MD         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona,, Spain
Contact: Alejandra Caballero    +34 93 489 4375    acaballero@vhio.net   
Principal Investigator: Jaume Capdevila         
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Contact: Teresa Vilella    +34 93 227 54 00 2811    VILELLA@clinic.cat   
Principal Investigator: Estela Pineda Losada         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Isabel Rodriguez    0034958020234    I_rodriguez_gonzalez@hotmail.es   
Principal Investigator: Encarnación Gonzalez Flores         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Ana Corcuera Sánchez    0034 91 426 93 94    acorcuera.hgugm@gmail.com   
Principal Investigator: Pilar-Garcia Alfonso, MD         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Sara Aragoneses    0034913368263    sara.aragoneses@salud.madrid.org   
Principal Investigator: Carmen Guillen Ponce, MD         
Hospital Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: Berta Martin    0034 91 550 48 00 ext 2299    BMartinL@fjd.es   
Principal Investigator: Ana Leon, MD         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain, 28220
Contact: Rocio Navarro    0034 911 917 418    rocio.navarro@salud.madrid.org   
Principal Investigator: Ana Ruiz Casado, MD         
Hospital Universitario Virgen de la Arrixaca Recruiting
Murcia,, Spain, 30120
Contact: Paula Ruiz Carreño    +34 968 36 93 87    dm.oncoarrixaca2@gmail.com   
Principal Investigator: Miguel Marin Vera         
Avenida de Roma, s/n, Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact: Cecilia Gonzalez    0034 985106100 Ext.36281    ceciliagonzalezd@hotmail.com   
Principal Investigator: Jose-Maria Vieitez, MD         
HCU Lozano Blesa, Planta 11-Oncología-Secretaría Recruiting
Zaragoza, Spain, 50009
Contact: Isabel Huércanos    0034 976 76 57 69    ihuercanos@iisaragon.es   
Principal Investigator: Maria Pilar Escudero Emperador, MD         
United Kingdom
Oxford University Hospitals NHS Foundation Trust Churchill Hospital Recruiting
Oxford, England, United Kingdom, OX3 7LI
Contact: Robin Peach-Toon    01865 572169    Robin.Peach-toon2@ouh.nhs.uk   
Principal Investigator: Rebecca Muirhead         
The Clatterbrdige Cancer Centre NHSF Trust Recruiting
Bebington, United Kingdom, CH63 4JY
Principal Investigator: Amir Montazeri         
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Robert Henley    +44 02920 615888    Robert.Henley@wales.nhs.uk   
Principal Investigator: Richard Adams         
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Caroline Brydon    0131 242 3739    Caroline.Brydon@nhslothian.scot.nhs.uk   
Principal Investigator: Ewan Brown, MD         
Beatson Cancer Centre and University of Glasgow Recruiting
Glasgow,, United Kingdom, G12 0YN
Contact: Austin McInnes    0141 301 7222    austin.mcinnes@glasgow.ac.uk   
Principal Investigator: Janet Graham         
University of Glasgow Recruiting
Glasgow, United Kingdom, G12 0YN
Principal Investigator: Janet Graham         
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Contact: Josh Harding    1483406612    josh.harding@nhs.net   
Principal Investigator: Tony Dhillon, MD         
Leeds Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Sam Higgs    +44 0113 20 67951    leedsth-tr.oncologytrials@nhs.net   
Principal Investigator: Daniel Swinson         
Royal Liverpool University Hospital Recruiting
Liverpool,, United Kingdom, L7 8XP
Contact: Jonathan Evans    01517062917    "jonathan.evans@rlbuht.nhs.uk   
Principal Investigator: Amir Montazeri         
UCLH, University College London Hospitals Recruiting
London, United Kingdom, NW1 2PG
Contact: Mahfuja Mahfuja    0203 447 7133    mahfuja.ahmed2@uclh.nhs.uk   
Principal Investigator: Steve Bandula, MD         
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Theodorah Nago    02071881466    theodorah.nago@gstt.nhs.uk   
Principal Investigator: Paul Ross, MD         
The Christie NHS Foundation Trust 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: Karen Newcombe    (0115) 9691169 Ex 54689 ext 54692    karen.newcombe@nuh.nhs.uk   
Principal Investigator: Jamie Mills, MD         
Oxford University Hospitals NHS Foundation Trust Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LI
Contact: Robin Peach-Toon    01865 572169    Robin.Peach-toon2@ouh.nhs.uk   
Principal Investigator: Rebecca Muirhead         
Western Park Hospital Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: Catharine Spalton    44(0)114 2265736    C.SPALTON@SHEFFIELD.AC.UK   
Principal Investigator: Joanne Hornbuckle, MD         
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Liane Davis    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
First Submitted: November 24, 2011
First Posted: December 1, 2011
Last Update Posted: September 1, 2017
Last Verified: August 2017

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