CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma

Uterine Leiomyosarcoma Clinical Trial

Official title: Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)

Status Recruiting

Clinical Trial Summary

The purpose of this study is to find out if giving a dose of heated chemotherapy in the abdomen immediately after surgery that is done to remove uterine leiomyosarcoma type of cancer will help lower the risk of the cancer coming back in the future.

Clinical Trial Description

Primary Objective:

• To assess the efficacy of cytoreductive surgery with gemcitabine HIPEC followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterine LMS.

Secondary Objectives:

• To assess the safety of cytoreductive surgery with gemcitabine HIPEC in subjects with locally recurrent uterine LMS.

• To assess the 6 month and 12 month intraabdominal relapse free survival in subjects with locally recurrent uterine LMS

• To determine quality of life prior to therapy (within 28 days prior to surgery with HIPEC), 4 to 6 weeks after surgery with HIPEC, and then at Cycle ;

Related Conditions & MeSH terms

• Leiomyosarcoma
• LMS - Leiomyosarcoma
• Uterine Leiomyosarcoma

• NCT number: NCT04727242
• Study type: Interventional
• Source: Stanford University
• Contact: Ghazal Jawed
• Phone: 650-724-1388
• Email: gjawed@stanford.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: January 28, 2021
• Completion date: January 2025