IRCI Gynae Sarcomas, High Grade Uterine Sarcoma
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|ClinicalTrials.gov Identifier: NCT01979393|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2013
Last Update Posted : October 13, 2021
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).
|Condition or disease||Intervention/treatment||Phase|
|Uterine Sarcoma||Drug: Cabozantinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2015|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||August 2023|
Cabozantinib maintenance 60 mg daily for 2 years or until withdrawal criterion After documented disease progression (according to RECIST 1.1), the treatment will be unblinded. Subjects receiving cabozantinib shall be further treated at the investigator discretion.
Placebo daily for 2 years or until withdrawal criterion. After documented disease progression (according to RECIST 1.1), the treatment will be unblinded. Subjects receiving placebo shall be offered the option of receiving cabozantinib up to further progression. This is not mandatory and treatment is at the investigator decision.
- Progression Free Survival (PFS) [ Time Frame: 3.5 years from first patient in ]The primary endpoint is PFS rate at 4 months after randomization to cabozantinib or placebo
- Progression free survival [ Time Frame: 3.5 years from first patient in ]
- Overall survival [ Time Frame: 3.5 years from first patient in ]
- Response rate [ Time Frame: 3.5 years from first patient in ]
- Duration of response to cabozantinib [ Time Frame: 3.5 years from first patient in ]
- Response rate to anthracycline-based chemotherapy for the patients with measurable disease [ Time Frame: 3.5 years from first patient in ]
- Assessment of global health status/QoL scale [ Time Frame: 3.5 years from first patient in ]The primary health-related quality of life endpoint that is considered of interest for this study is the global health status/QoL scale
- Occurence of Adverse Events [ Time Frame: 3.5 years from first patient in ]This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
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): NCT01979393
|Universitair Ziekenhuis Antwerpen|
|Bordeaux, France, 33076|
|Dijon, France, 21079|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau|
|Fondazione IRCCS Istituto Nazionale dei Tumori|
|Milano, Italy, 20133|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Hospital General Vall D'Hebron|
|Barcelona, Spain, 08035|
|Hospital Universitario San Carlos|
|Madrid, Spain, 28040|
|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|
|Study Chair:||Isabelle Ray-Coquard, MD||Centre Léon Bérard, Lyon, France|
|Principal Investigator:||Nicholas Reed, MD||NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital , Glasgow, United Kingdom|