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Summary

Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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

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

  • St. Marks Hospital accepting new patients
    Salt Lake City, Utah, 84124, United States
  • University of Washington accepting new patients
    Seattle, Washington, 98195, United States
  • UT Southwestern Medical Center accepting new patients
    Dallas, Texas, 75390, United States
  • M D Anderson Cancer Center accepting new patients
    Houston, Texas, 77030, United States
  • Virginia Piper Cancer Institute, Abbott Northwestern Hospital 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
  • Washington University accepting new patients
    St Louis, Missouri, 63110, United States
  • University of Wisconsin Hospital & Clinics withdrawn
    Madison, Wisconsin, 53792, United States
  • Medical College of Wisconsin, Inc. accepting new patients
    Milwaukee, Wisconsin, 53226, United States
  • Rush University Medical Center accepting new patients
    Chicago, Illinois, 60612, United States
  • Northwestern Memorial Hospital 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 accepting new patients
    Grand Rapids, Michigan, 49503, United States
  • Spectrum Health / Advanced Radiology Services accepting new patients
    Grand Rapids, Michigan, 49506, United States
  • University of Louisville accepting new patients
    Louisville, Kentucky, 40202, United States
  • Miami Valley Hospital accepting new patients
    Dayton, Ohio, 45409, United States
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, 48109, United States
  • Karmanos Cancer Institute accepting new patients
    Detroit, Michigan, 48201, United States
  • Ohio State University accepting new patients
    Columbus, Ohio, 43210, United States
  • Cleveland Clinic Foundation accepting new patients
    Cleveland, Ohio, 44195, United States
  • Cleveland Clinic Foundation accepting new patients
    Cleveland, Ohio, 44195, United States
  • London Regional Cancer Centre accepting new patients
    London, Ontario, N6A 4L6, Canada
  • Mount Sinai Hospital accepting new patients
    Toronto, Ontario, M5G 1X5, Canada
  • Moffit Cancer Center accepting new patients
    Tampa, Florida, 33612, United States
  • University of Rochester, James P Wilmot Cancer Ctr accepting new patients
    Rochester, New York, 14642, United States
  • University of Virginia Health System accepting new patients
    Charlottesville, Virginia, 22908, United States
  • George Washington University Hospital withdrawn
    Washington, District of Columbia, 20037, United States
  • The Johns Hopkins Hospital withdrawn
    Baltimore, Maryland, 21287, United States
  • Sentara Cancer Research accepting new patients
    Norfolk, Virginia, 23507, United States
  • Hospital of the University of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Diagnostic Imaging Inc accepting new patients
    Trevose, Pennsylvania, 19053, United States
  • University of Miami Miller School of Medicine, Florida accepting new patients
    Miami, Florida, 33136, United States
  • McGill University Health Centre / Royal Victoria Hospital accepting new patients
    Montreal, Quebec, H3A 1A1, Canada
  • Lahey Clinic - Tufts University accepting new patients
    Burlington, Massachusetts, 01805, United States
  • QEII Health Services Center accepting new patients
    Halifax, Nova Scotia, B3H 3A7, Canada
  • Churchill Hospital accepting new patients
    Oxford, England, OX3 7LE, United Kingdom
  • Edinburgh Cancer Centre - Western General Hospital accepting new patients
    Edinburgh, EH4 2XU, United Kingdom
  • Royal Surrey County Hospital accepting new patients
    Guildford, GU2 7XX, United Kingdom
  • University College London Hospitals Foundation NHS Trust accepting new patients
    London, NW1 2BU, United Kingdom
  • Guy's Hospital accepting new patients
    London, SE1 9RT, United Kingdom
  • The Christie, Manchester 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
  • Western Park Hospital - Sheffield Teaching Hospitals Trial Center accepting new patients
    Sheffield, NW3 2QG, United Kingdom
  • University Hospital Southampton, Southampton General Hospital accepting new patients
    Southampton, SO16 6YD, United Kingdom
  • AZ - Sint Lucas Ziekemhuis accepting new patients
    Gent, Oost-Vlaander, 9000, Belgium
  • VZW 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 - imagerie medical accepting new patients
    Montpellier, Cedex 5, 34295, France
  • CHU d'Angers, Gastroenterologie, Endoscopie & Oncologie digestive Médecine accepting new patients
    Angers, Cedex 9, 49933, France
  • CHU Toulouse, Hôpital Rangueil accepting new patients
    Toulouse, Cedex 9, 31059, France
  • Hôpital Henri Mondor, Oncologie médical accepting new patients
    Créteil, 94010, France
  • Hotel-Dieu, Service d'Hepatogastro-enterologie accepting new patients
    Nantes, 44093, France
  • CHU de Nice, Hôpital de l'Archet, Radiology accepting new patients
    Nice, 6202, France
  • Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie accepting new patients
    Poitiers, 86000, France
  • Centre Eugene Marquis accepting new patients
    Rennes, 35042, France
  • Hospital Universitario Puerta de Hierro accepting new patients
    Majadahonda, Madrid, 28220, Spain
  • Hospital Universitario Ramon y Cajal accepting new patients
    Madrid, 28034, Spain
  • University Hospital "Fundacion Jimenez Diaz" accepting new patients
    Madrid, 28040, Spain
  • Hospital General Universitario Gregorio Maronon accepting new patients
    Mardid, 28007, Spain
  • Hospital Universitaario Central de Asturias accepting new patients
    Oviedo, 33011, Spain
  • Hospital Clínico Lozano Blesa, Zaragoza accepting new patients
    Zaragoza, 50009, Spain
  • Clinici of Imaging Methods - University Hospital Plzen withdrawn
    Plzen, 30640, Czech Republic
  • Medical University of Vienna accepting new patients
    Vienna, 1210, Austria
  • Universitaria di Bologna accepting new patients
    Bologna, 40138, Italy
  • Hong Kong Sanatorium and Hospital accepting new patients
    Hong Kong, China
  • Queen Mary Hospital accepting new patients
    Hong Kong, China
  • National University Hospital Singapore accepting new patients
    Singapore, 119228, Singapore
  • National University Hospital accepting new patients
    Singapore, 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
July 18, 2016
I’m interested in this study!