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

NCT04727242 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • LMS - Leiomyosarcoma
  • Uterine 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

Sponsors & Collaborators

Principal Investigators

  • Kristen N Ganjoo, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727242 on ClinicalTrials.gov