Symptoms and General Pathology

All Conditions

Wounds and Injuries

Neoplasms

Rare Diseases

Recurrence

Hyperthermia

Fever

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Dacarbazine

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

* Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine followed by postoperative systemic chemotherapy with dacarbazine. Conceptually, HIPEC will be administered as a 60 minute heated intraperitoneal infusion (ie, intraperitoneal "wash" or "lavage").
* HIPEC: Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C.
* Systemic adjuvant chemotherapy starting 30 days ± 14 days post surgery. Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles

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

Cytoreductive Surgery

Preoperative and Postoperative FACT G questionnaire to assess QoL

Functional Assessment of Cancer Therapy (FACT) G questionnaire

Radiologic imaging after Cycle 3 and 6 and at each follow up visit

Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan

Gadolinium

Ghazal Jawed

Kristen N Ganjoo, MD

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

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

Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)

Progression free survival as measured from the time of surgery until death or disease progression.

Rate of Grade 4 infections within 30 days post surgery with gemcitabine HIPEC will be assessed using CTCAE version 5.0.

Relapse free survival as measured from time of surgery until intraabdominal recurrence

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma	NCT04727242	LMS - Leiomyosa... Uterine Leiomyo...	Gemcitabine Dacarbazine Cytoreductive S... Functional Asse... Computed Tomogr... Gadolinium	18 Years -	Stanford University
CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma	NCT04727242	LMS - Leiomyosa... Uterine Leiomyo...	Gemcitabine Dacarbazine Cytoreductive S... Functional Asse... Computed Tomogr... Gadolinium	18 Years -	Stanford University

Spots Global Cancer Trial Database for functional assessment of cancer therapy (fact) g questionnaire