Spots Global Cancer Trial Database for CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma

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Trial Identification

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

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)

Study ID: NCT04727242

Conditions

LMS - Leiomyosarcoma

Uterine Leiomyosarcoma

Interventions

Gemcitabine

Dacarbazine

Cytoreductive Surgery

Functional Assessment of Cancer Therapy (FACT) G questionnaire

Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan

Gadolinium

Study Description

Brief 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.

Detailed 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