Uterine LMS study
Research type
Research Study
Full title
A Phase III Randomised Trial of Gemcitabine plus Docetaxel followed by Doxorubicin versus observation for uterus-limited, high grade uterine leiomyosarcoma
IRAS ID
110703
Contact name
Karen Carty
Contact email
Sponsor organisation
EORTC
Eudract number
2012-002852-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
Uterine Leiomyosarcoma (ULMS) is rare but even patients with early stage disease have a high (50-70%) chance of their disease returning (recurring). Recurrences may be distant or local or both. The current management for patients with leiomyosarcoma of the uterus which been completely removed by surgery is to follow patients closely to check if they have evidence of recurrence. Currently when leiomyosarcoma recurs the leiomyosarcoma may be treated with chemotherapy, surgery or radiotherapy depending on where the recurrence has occurred. If the recurrence is not suitable for surgery or radiotherapy chemotherapy drugs may be offered to reduce the disease or control symptoms which may be associated with the recurrence such as pain. There are several drugs that can shrink leiomyosarcoma tumours, these include the combination treatment of gemcitabine and docetaxel, and doxorubicin. In this study we are looking to see if giving chemotherapy with gemcitabine plus docetaxel followed by doxorubicin to patients whose leiomyosarcoma was found only in the uterus decreases the chance that the leiomyosarcoma recurs. In this study half the patients will be managed in the standard way which is to follow them closely with CT scans and see if disease recurs. The other half of patients will be treated with chemotherapy and also followed to see if disease recurs. We will learn from this study whether or not chemotherapy lowers the chance of the leiomyosarcoma recurring and whether or not the patients with chemotherapy live longer than the patients who are observed. If the leiomyosarcoma recurs in either group other treatments will be offered to both groups according to standard treatments.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0011
Date of REC Opinion
13 Mar 2013
REC opinion
Further Information Favourable Opinion