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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

Keywords

Colorectal Cancer Metastatic Colorectal Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Fransico, Moffitt Hospital accepting new patients
    San Francisco, California, 94143, United States
  • St. Marks Hospital accepting new patients
    Salt Lake City, Utah, 84124, United States
  • University of Washington accepting new patients
    Seattle, Washington, 98109, United States
  • University of Washington accepting new patients
    Seattle, Washington, 98195, United States
  • University of Colorado Denver Anschutz Medical Campus accepting new patients
    Aurora, Colorado, 80045, United States
  • University of Colorado, Denver accepting new patients
    Aurora, Colorado, 80045, United States
  • Royal University Hospital accepting new patients
    Saskatoon, Saskatchewan, Saskatchewan, S7N 0W8, Canada
  • Royal University Hospital accepting new patients
    Saskatchewan, S7N 0W8, Canada
  • UT Southwestern Medical Center at Dallas accepting new patients
    Dallas, Texas, 75390-8834, United States
  • UT Southwestern Medical Center accepting new patients
    Dallas, Texas, 75390, United States
  • UT MD Anderson Cancer Center accepting new patients
    Houston, Texas, 77030, United States
  • Allina Health, Virginia Piper Cancer Institute accepting new patients
    Minneapolis, Minnesota, 55407, United States
  • Minneapolis accepting new patients
    Minneapolis, Minnesota, 55407, United States
  • Mayo Clinic withdrawn
    Rochester, Minnesota, 55905, United States
  • Gundersen Medical Foundation accepting new patients
    La Crosse, Wisconsin, 54601, United States
  • Mallinckrodt Institute of Radiology accepting new patients
    Saint Louis, Missouri, 63110, United States
  • University of Wisconsin Hospital & Clinics withdrawn
    Madison, Wisconsin, 53792, United States
  • Carle Clinic accepting new patients
    Urbana, Illinois, 61801, United States
  • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital accepting new patients
    Milwaukee, Wisconsin, 53226, United States
  • Aurora Research Institute accepting new patients
    Wauwatosa, Wisconsin, 53226, United States
  • Rush University Medical Center accepting new patients
    Chicago, Illinois, 60612, United States
  • Northwestern University accepting new patients
    Chicago, Illinois, 60611, United States
  • Indiana University School of Medicine accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Saint Mary's Healthcare withdrawn
    Grand Rapids, Michigan, 49503, United States
  • Spectrum Health accepting new patients
    Grand Rapids, Michigan, 49503, United States
  • University of Louisville accepting new patients
    Louisville, Kentucky, 40202, United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham, Alabama, 35249, United States
  • University of Alabama accepting new patients
    Birmingham, Alabama, 35249, United States
  • Miami Valley Hospital accepting new patients
    Dayton, Ohio, 45409, United States
  • University of Michigan Health System accepting new patients
    Ann Arbor, Michigan, 48109, United States
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, 48109, United States
  • Wayne State Harper Hospita Karmanos Cancer Institute accepting new patients
    Farmington Hills, Michigan, 48334, United States
  • Beaumont Hospital accepting new patients
    Royal Oak, Michigan, 48073, United States
  • The Ohio State University, Wexner Medical Center accepting new patients
    Columbus, Ohio, 43210, United States
  • Cleveland Clinic Foundation accepting new patients
    Cleveland, Ohio, 44195, United States
  • London Regional Cancer program accepting new patients
    London, Ontario, N6A 4L6, Canada
  • University Health Network , Mount Sinai Hospital accepting new patients
    Toronto, Ontario, Ontario, M5G 2C4, Canada
  • Moffit Cancer Center accepting new patients
    Tampa, Florida, 33612, United States
  • University of Rochester accepting new patients
    Rochester, New York, 14642, United States
  • University of Virginia Health System withdrawn
    Charlottesville, Virginia, 22908, United States
  • George Washington University Hospital withdrawn
    Washington, D.C., District of Columbia, 20037, United States
  • The Johns Hopkins Hospital withdrawn
    Baltimore, Maryland, 21287, United States
  • Christiana Care Hospital accepting new patients
    Newark, Delaware, 19713, United States
  • Sentara Norfolk General accepting new patients
    Norfolk, Virginia, 23507, United States
  • University of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Aria Health accepting new patients
    Trevose, Pennsylvania, 19053, United States
  • Lynn Clinical Research Center, Boca Raton Regional Hospital accepting new patients
    Boca Raton, Florida, 33486, United States
  • University of Miami Miller School of Medicine, Florida accepting new patients
    Miami, Florida, 33136, United States
  • McGill University Health Center - Glen Site accepting new patients
    Montreal, Quebec, Quebec, H4A 3J1, Canada
  • Memorial Sloan Kettering Cancer Center accepting new patients
    New York, New York, 10065, United States
  • Lahey Clinic - Tufts withdrawn
    Burlington, Massachusetts, 01805, United States
  • QEII Health Services Center, Halifax Infirmary Site accepting new patients
    Halifax, Nova Scotia, B3H 3A7, Canada
  • Oxford University Hospitals NHS Foundation Trust Churchill Hospital accepting new patients
    Oxford, England, OX3 7LI, United Kingdom
  • The Clatterbrdige Cancer Centre NHSF Trust accepting new patients
    Bebington, CH63 4JY, United Kingdom
  • Velindre Cancer Centre accepting new patients
    Cardiff, CF14 2TL, United Kingdom
  • Western General Hospital accepting new patients
    Edinburgh, EH4 2XU, United Kingdom
  • Beatson Cancer Centre and University of Glasgow accepting new patients
    Glasgow,, G12 0YN, United Kingdom
  • University of Glasgow accepting new patients
    Glasgow, G12 0YN, United Kingdom
  • Royal Surrey County Hospital accepting new patients
    Guildford, GU2 7XX, United Kingdom
  • Leeds Hospitals NHS Trust accepting new patients
    Leeds, LS9 7TF, United Kingdom
  • Royal Liverpool University Hospital accepting new patients
    Liverpool,, L7 8XP, United Kingdom
  • UCLH, University College London Hospitals accepting new patients
    London, NW1 2PG, United Kingdom
  • Guy's and St Thomas' NHS Foundation Trust accepting new patients
    London, SE1 9RT, United Kingdom
  • The Christie NHS Foundation Trust accepting new patients
    Manchester, M20 4BX, United Kingdom
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust accepting new patients
    Newcastle, NE7 7DN, United Kingdom
  • Nottingham University Hospital NHS Trust accepting new patients
    Nottingham, NG5 1PB, United Kingdom
  • Oxford University Hospitals NHS Foundation Trust Churchill Hospital accepting new patients
    Oxford, OX3 7LI, United Kingdom
  • Western Park Hospital accepting new patients
    Sheffield, S10 2SJ, United Kingdom
  • Southampton General Hospital accepting new patients
    Southampton, SO16 6YD, United Kingdom
  • Onze-Lieve-Vrouwziekenuis VZW Campus Aalst accepting new patients
    Aalst, 9300, Belgium
  • AZ - Sint Lucas accepting new patients
    Gent, 9000, Belgium
  • AZ Groeninge accepting new patients
    Kortrijk, 8500, Belgium
  • Gangnam Severance Hospital accepting new patients
    Seoul, Korea, Republic of
  • Korea University Anam Hospital accepting new patients
    Seoul, Korea, Republic of
  • Seoul National University Hospital accepting new patients
    Seoul, Korea, Republic of
  • Severance Hospital accepting new patients
    Seoul, Korea, Republic of
  • St. Mary's Hospital accepting new patients
    Seoul, Korea, Republic of
  • CHRU Montpellier - Hopital St Eloi accepting new patients
    Montpellier, Cedex 5, 34295, France
  • CUH d'Angers accepting new patients
    Angers, Cedex 9, 49933, France
  • CHU Toulouse, Hôpital Rangueil accepting new patients
    Toulouse, Cedex 9, 31059, France
  • Institut Bergognié accepting new patients
    Bordeaux, 33076, France
  • Hôpital Henri Mondor accepting new patients
    Créteil, 94010, France
  • Centre Georges Francois Leclerc accepting new patients
    Dijon cedex, 21000, France
  • Hôpital La Timone accepting new patients
    Marseille, 13005, France
  • CHU Nantes-Hôtel Dieu accepting new patients
    Nantes, 44093, France
  • CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2 accepting new patients
    Nice, 6202, France
  • CHU Bordeaux accepting new patients
    Pessac, 33600, France
  • Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie accepting new patients
    Poitiers, 86000, France
  • Centre Eugene Marquis accepting new patients
    Rennes, 35000, France
  • Universitätsklinikum Bonn accepting new patients
    Bonn,, 53127, Germany
  • Universitätsklinikum Essen accepting new patients
    Essen, 45122, Germany
  • Medizinische Hochschule Hannover accepting new patients
    Hannover, 30625, Germany
  • SLK Kliniken, Heilbronn GmbH accepting new patients
    Heilbronn, 74078, Germany
  • University Hospital of Leipzig accepting new patients
    Leipzig, 04103, Germany
  • Eberhard-Karls-University Tübingen accepting new patients
    Tübingen, 72076, Germany
  • Hospital Universitari Vall d'Hebron accepting new patients
    Barcelona,, Spain
  • Hospital Clinic de Barcelona accepting new patients
    Barcelona, 8036, Spain
  • Hospital Universitario Virgen de las Nieves accepting new patients
    Granada, 18014, Spain
  • Hospital General Universitario Gregorio Marañón accepting new patients
    Madrid, 28007, Spain
  • Hospital Universitario Ramon y Cajal accepting new patients
    Madrid, 28034, Spain
  • Hospital Fundación Jiménez Díaz accepting new patients
    Madrid, 28040, Spain
  • Hospital Universitario Puerta de Hierro accepting new patients
    Madrid, 28220, Spain
  • Hospital Universitario Virgen de la Arrixaca accepting new patients
    Murcia,, 30120, Spain
  • Avenida de Roma, s/n, Hospital Universitario Central de Asturias accepting new patients
    Oviedo, 33011, Spain
  • HCU Lozano Blesa, Planta 11-Oncología-Secretaría accepting new patients
    Zaragoza, 50009, Spain
  • Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie accepting new patients
    Gliwice, Poland
  • Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego accepting new patients
    Grudziądz, Poland
  • Centralny Szpital Kliniczny MSWiA accepting new patients
    Warszawa, Poland
  • Centrum Onkologii - Instytut accepting new patients
    Warszawa, Poland
  • Centrum Onkologii - Instytut accepting new patients
    Warszawa, Poland
  • Wojskowy Instytut Medyczny accepting new patients
    Warszawa, Poland
  • Clinici of Imaging Methods - University Hospital Plzen withdrawn
    Plzen, 30640, Czechia
  • Medical University of Vienna accepting new patients
    Vienna, 1090, Austria
  • Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi accepting new patients
    Bologna, 40138, Italy
  • Hong Kong Sanatorium Hospital accepting new patients
    Hong Kong, China
  • Queen Mary Hospital accepting new patients
    Hong Kong, China
  • National University Hospital accepting new patients
    Singapore, 119228, Singapore

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BTG International Inc.
ID
NCT01483027
Phase
Phase 3
Lead Scientist
Nicholas Fidelman
Study Type
Interventional
Last Updated
August 31, 2017
I’m interested in this study!