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IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

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Purpose: Find out if taking a relatively new drug (cabozantinib) after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy.
Authoritative site for this trial:  At clinicaltrials.gov
What is the treatment?  All patients will receive standard chemotherapy. Those patients with some kind of a positive response (slowing down or stopping progression) to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).
Is there a chance you'll get a placebo? Yes, this is a placebo controlled trial. It compares how the disease is affected by the drug to to patients recruited who do not get the drug. (see Glossary for placebo-controlled trial)
How old do you have to be?  18 years old ior older (not children)
What phase study is this?  It's a phase II study
What includes you in trial?  You're newly diagnosed with stage III or stage IV or residual disease after surgery to remove the primary tumor. Or you're diagnosed with metastatic disease with relapse. A pathologist must review the diagnosis of sarcoma (from the tumor tissue). Also apart from the tumor, your organs are working, including normal heart function.
What excludes you from the trial?
  • Less aggressive (“low grade”) tumor. Any tumor type other than uterine sarcoma
  • Can’t swallow pills
  • Currently involved in other trial or planning to use other treatments.
  • Untreated low thyroid function.(This can be fixed within a week by an endocrinologist)
  • Very high blood pressure (more than 150/90)
  • Strokes or blood clots or bleeding inside organs or visible on skin.
  • Diseases of your gut (e.g. ulcerative colitis).
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    In USA?  No
    Sites where the trial is offered: France, Spain, Italy, Netherlands, United Kingdom (see below)
    Contact information: Overall contacts are: Ellen Peeters +32 2 7741082 ellen.peeters@eortc.be and Vinciane Vinckx +32 2 7741032 vinciane.vinckx@eortc.be
  • Belgium: Universitair Ziekenhuis Antwerpen Edegem, Belgium Principal Investigator: Manon Huizing
  • France: Institut Bergonie Recruiting Bordeaux, France, 33076 Contact: Contact Person 33-556-333-333 Principal Investigator: Anne Floquet
  • France: Centre Georges-Francois-Leclerc Recruiting Dijon, France, 21079 Principal Investigator: Nicolas Isambert
  • France: Centre Leon Berard Recruiting Lyon, France, 69373 Contact: Contact Person 33-4-7878-2645 Principal Investigator: Isabelle Ray-Coquard
  • France: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau Recruiting Nantes, France Principal Investigator: Emmanualle Bompas
  • Italy: Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting Milano, Italy, 20133 Principal Investigator: Paolo Casali
  • Netherlands: Academisch Medisch Centrum at University of Amsterdam Recruiting Amsterdam, Netherlands, 1105 AZ Principal Investigator: Anneke Westermann, MD
  • Spain: Hospital General Vall D'Hebron Recruiting Barcelona, Spain, 08035 Principal Investigator: Claudia Valverde
  • Spain: Hospital Universitario San Carlos Recruiting Madrid, Spain, 28040 Principal Investigator: Antonio Casado
  • United Kingdom: Cambridge University Hospital NHS - Addenbrookes Hospital Recruiting Cambridge, United Kingdom Principal Investigator: Helena Earl
  • United Kingdom: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital Recruiting Glasgow, United Kingdom Principal Investigator: Nick Reed
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