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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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 1000 mg/m2 IV every 3 weeks x 6 cycles given IV
Surgery for cancer removal
Stanford University
Stanford, California, United States
Progression free survival (PFS)
Progression free survival as measured from the time of surgery until death or disease progression.
Time frame: 1 year
Rate of Grade 4 infections
Rate of Grade 4 infections within 30 days post surgery with gemcitabine HIPEC will be assessed using CTCAE version 5.0.
Time frame: 30 days post surgery with gemcitabine HIPEC
Intraabdominal relapse free survival
Relapse free survival as measured from time of surgery until intraabdominal recurrence
Time frame: 6 months
Intraabdominal relapse free survival
Relapse free survival as measured from time of surgery until intraabdominal recurrence
Time frame: 12 months
Overall Functional Assessment of Cancer Therapy: General (FACT G) score
Difference in overall FACT G score from baseline to 4 to 6 weeks post-surgery with gemcitabine HIPEC. FACT G is a quality of life questionnaire composed of 27 items divided into four main quality of life categories: Physical Well Being (PWB); Social/Family Well Being (SWB); Emotional Well Being (EWB); and Functional Well Being (FWB). Total FACT G score is obtained by summing the scores from the four main QoL categories (PWB; SWB; EWB; FWB). The range of the scale is 0-108. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better Quality of life (Qol).
Time frame: Baseline, 4 to 6 weeks post-surgery with HIPEC
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Preoperative and Postoperative FACT G questionnaire to assess QoL
Radiologic imaging after Cycle 3 and 6 and at each follow up visit
Contrast Agent