NCT00282087

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sarcoma Alliance for Research through Collaboration · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leiomyosarcoma
• Uterine Neoplasm

Interventions

Type	Name	Description
DRUG	gemcitabine, docetaxel, doxorubicin	Cycles = 28 days

Timeline

• Start date: 2006-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2006-01-25
• Last updated: 2014-12-01
• Results posted: 2014-12-01

Locations

12 sites across 1 country: United States