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 - Cabozantinib maintenance in HGUtS

European Organisation for Research in Treatment of Cancer (EORTC)0 sites6 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

European Organisation for Research in Treatment of Cancer (EORTC)

•1\) At registration, \- Patients who are suitable for treatment with doxorubicin
•\+/\- ifosfamide and fall within one of the following patient populations:
•\* HGUS, HGESS, HGLMS and HG adenosarcoma:
•\* FIGO stage II and stage III : if adjuvant chemotherapy is proposed
•\* FIGO stage IV: if first line chemotherapy is proposed, \-Patients can be
•registered no earlier than 4 weeks prior to start of the 1st line treatment and
•no later than 4 weeks after last administration of 1st line treatment., \- 1
•formalin fixed paraffin embedded (FFPE) block of tumor tissue (if not
•available, at least 1 H/E (haematoxylin/eosin) and 15 unstained slides) is sent
•after registration of a patient. Histological central review is mandatory to

•At randomization, \- The following tumor types are NOT eligible: low\-grade ESS,
•leiomyosarcoma (low or intermediate), carcinosarcoma, low\-grade adenosarcoma,
•rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of
•uterus/cervix., \- No contraindications to cabozantinib (e.g. no known immediate
•or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically
•related to cabozantinib), \- No planned use of chemotherapy, radiation therapy,
•radionuclide treatment, small molecule TKI or hormonal therapy, and any other
•investigational agent during the treatment period., \- No prior treatment with
•cabozantinib, \- No concurrent severe, clinically relevant hypothyroidism or
•thyroid dysfunction within 7 days before the first dose of study treatment, \-

Not specified