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CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
Sponsor: Stanford University
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
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.
Dacarbazine
Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV
Cytoreductive Surgery
Surgery for cancer removal
Functional Assessment of Cancer Therapy (FACT) G questionnaire
Preoperative and Postoperative FACT G questionnaire to assess QoL
Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan
Radiologic imaging after Cycle 3 and 6 and at each follow up visit
Gadolinium
Contrast Agent
Locations (1)
Stanford University
Stanford, California, United States