NCT04727242View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 28, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
LMS - LeiomyosarcomaUterine Leiomyosarcoma
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

Trial Locations (1)

94305

RECRUITING

Stanford University, Stanford

All Listed Sponsors
lead

Kristen Ganjoo

OTHER