NCT04727242

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• LMS - Leiomyosarcoma
• Uterine Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine. Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C.
DRUG	Dacarbazine	Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV
PROCEDURE	Cytoreductive Surgery	Surgery for cancer removal
BEHAVIORAL	Functional Assessment of Cancer Therapy (FACT) G questionnaire	Preoperative and Postoperative FACT G questionnaire to assess QoL
PROCEDURE	Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan	Radiologic imaging after Cycle 3 and 6 and at each follow up visit
DRUG	Gadolinium	Contrast Agent

Timeline

• Start date: 2021-01-28
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2021-01-27
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study