NCT01979393

IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Uterine Sarcoma

Interventions

Type	Name	Description
DRUG	Cabozantinib
DRUG	Placebo

Timeline

• Start date: 2015-02-02
• Primary completion: 2022-05-18
• Completion: 2024-01-15
• First posted: 2013-11-08
• Last updated: 2025-08-01

Locations

15 sites across 5 countries: France, Italy, Netherlands, Spain, United Kingdom