Spots Global Cancer Trial Database for Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

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Trial Identification

Brief Title: Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Official Title: Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial

Study ID: NCT00282087

Conditions

Leiomyosarcoma

Uterine Neoplasm

Interventions

gemcitabine, docetaxel, doxorubicin

Study Description

Brief Summary: The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Detailed Description: Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.