Spots Global Cancer Trial Database for IRCI Gynae Sarcomas, High Grade Uterine Sarcoma
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Trial Identification
Brief Title: IRCI Gynae Sarcomas, High Grade Uterine Sarcoma
Official Title: A Randomized Double-blind Phase II Study Evaluating the Role of Maintenance Therapy With Cabozantinib in High Grade Uterine Sarcoma (HGUtS) After Stabilization or Response to Doxorubicin +/- Ifosfamide Following Surgery or in Metastatic First Line Treatment
Study ID: NCT01979393
Conditions
Study Description
Brief Summary: This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread. Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy. All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Institut Bergonie, Bordeaux, , France
Institut Bergonie, Bordeaux, , France
Centre Leon Berard, Lyon, , France
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau, Nantes, , France
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Academisch Medisch Centrum at University of Amsterdam, Amsterdam, , Netherlands
Hospital General Vall D'Hebron, Barcelona, , Spain
Hospital Universitario San Carlos, Madrid, , Spain
Cambridge University Hospital NHS - Addenbrookes Hospital, Cambridge, , United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital, Leeds, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Isabelle Ray-Coquard, MD
Affiliation: Centre Léon Bérard, Lyon, France
Role: STUDY_CHAIR
Name: Nicholas Reed, MD
Affiliation: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital , Glasgow, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
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