HGUtS Study
Research type
Research Study
Full 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
IRAS ID
155221
Contact name
Helen Hatcher
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2013-000762-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
The International Rare Cancer Initiative (IRCI) has been set up as an international collaboration to improve outcomes for patients diagnosed with rare cancers. The collaboration is between Cancer Research UK, and the NCRN/NCRI in the UK; the European Organisation for the Research and Treatment of Cancer(EORTC); and the National Cancer Institute (NCI) in the US.
High grade undifferentiated uterine sarcoma (HGUS, accounts for only 5-10% of uterine sarcomas which comprise only 3%-7% of all uterine cancers. HGUS has a very poor prognosis and most patients die of recurrent disease within two years of diagnosis. Local recurrence and distant metastases are associated with a median survival of less than one year. The principles of management include palliative systemic chemotherapy for locally advanced disease or metastatic disease. Standard systemic treatment for HGUS parallels that for adult type soft tissue sarcomas (STS), using doxorubicin +/- ifosfamide, as single agents or in combination.
This trial is set up to recruit patients with a diagnosis of advanced HGUS, and offer standard treatment with doxorubicin +/- ifosfamide. After 4-6 cycles, those patients responding or with stable disease will be offered randomisation to treatment with cabozantinib or placebo, in the form of daily tablets. Cabozantinib is new chemical entity that inhibits the receptor tyrosine kinases VEGFR2, MET and RET. These targets are important mediators of tumour growth and angiogenesis (new blood vessel formation). In addition MET is particularly associated with tumour invasiveness and metastasis, and therefore its inhibition should slow down tumour progression. The primary endpoint of the study is progression free survival (PFS) at 4 months, and will be assessed by CT scan. At progression patients randomised to placebo, can be offered cross over to cabozantinib, at the discretion of their responsible consultant.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0073
Date of REC Opinion
21 Apr 2015
REC opinion
Further Information Favourable Opinion