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

  • STATUS
    Not Recruiting
  • End date
    Sep 24, 2023
  • participants needed
    25
  • sponsor
    Stanford University
Updated on 2 June 2022

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.

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

Details
Condition LMS - Leiomyosarcoma, Uterine Leiomyosarcoma
Treatment Gemcitabine, dacarbazine, cytoreductive surgery, Gadolinium, Functional Assessment of Cancer Therapy (FACT) G questionnaire, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan
Clinical Study IdentifierNCT04727242
SponsorStanford University
Last Modified on2 June 2022

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