A phase III randomized trial of gemcitabine (nsc# 613327) plus docetaxel (nsc# 628503) followed by doxorubicin (nsc# 123127) versus observation for uterus-limited, high-grade uterine leiomyosarcoma
Principal Investigator
Martee Hensley, MD
Status
Terminated
Date Opened To Accrual
June 04 2012
Date Closed to Accrual
September 20 2016
Date of Study Termination
February 09 2019
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin compared to patients assigned to observation.
Patient Population
Patients with high risk uterine LMS, FIGO stage I (confined to corpus +/- cervix). Patients with known uterine serosa involvement are not eligible. Patients should have had, at least, a complete hysterectomy (including removal of the cervix). Bilateral salpingo-oophorectomy is not required.
Target Accrual
216
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.