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ACTIVE NOT RECRUITING
NCT04727242
PHASE2

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2021-01-28

Completion Date

2026-05

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

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

Locations (1)

Stanford University

Stanford, California, United States