Cabozantinib in High Grade Uterine Sarcoma (HGUtS)


Maintenance therapy with Cabozantinib in High Grade Uterine Sarcoma (HGUtS)

Agents: Cabozantinib
Phase II
Status  Open, recruiting
Sponsor EORTC

 

Further information: https://clinicaltrials.gov/ct/show/NCT01979393 or http://www.eortc.org/research_field/clinical-detail/62113/

 

A phase II study evaluating the role of maintenance therapy with Cabozantinib in High Grade Uterine Sarcoma (HGUtS) after stabilization or response to chemotherapy

WHO is the trial for?
  • Adult female patients (18 years or older) with confirmed advanced high-grade uterine sarcoma (stage III or IV) or with residual disease or relapse after primary surgery
  • Patients should be stable after or have responded to first line treatment with chemotherapy (anthracyclines alone or in combination with ifosfamide)
  • Overall health status of the patient has to be good (WHO/ECOG performance status 0-2)
  • Adequate cardiac, organ and bone marrow function

WHAT is the key question that this trial is attempting to answer?

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.


This trial tries 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.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

 The study is open (recruiting) for participation.

WHERE is the trial available?

The trial is available in several study centers in the France, Belgium, The Netherlands, Spain, Italy and the UK. For further information please check here: http://www.eortc.org/research_field/clinical-detail/62113/ or https://clinicaltrials.gov/ct/show/NCT01979393

Study contact:
  • Ellen Peeters, EORTC
    Phone: +32 2 7741082
    E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
  • Vinciane Vinckx, EORTC
    Phone: +32 2 7741032
    E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

STUDY DESIGN: What does the study look like?

All participants will receive 4-6 cycles of standard chemotherapy. Then, there will be 2 study arms (groups): those patients with stabilization or response to the standard chemotherapy will be randomly divided (by a computer) in two groups and receive either cabozantinib or placebo.

 SPAEN Study Registry CABO HGUtS Design

 

HOW do I get more information?

 Patient organisations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

CONNECT with other patients on this trial

 If you want to connect with other patients considering or participating in this trial, you can find them here.

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 No results are available at this time. Future results will be linked here.


Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken