Surgery + HIPEC with Chemotherapy for Uterine Cancer

Overseen by Kristen N Ganjoo, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial uses heated chemotherapy in the abdomen to treat patients with recurring uterine cancer. The heat helps the drug work better, and additional medication is given to target any remaining cancer cells.

Research Team

Kristen N Ganjoo, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults with confirmed uterine leiomyosarcoma who are candidates for aggressive surgery to remove the cancer. They must have a certain level of blood cells, liver and kidney function, and be able to sign consent. Pregnant or breastfeeding women, those with active infections or unresolved treatment side effects (except hair loss), prior non-adjuvant gemcitabine use, recent recurrence after gemcitabine, metastatic liver disease, or active extra abdominal disease cannot join.

Inclusion Criteria

Prothrombin Time (PT) such that international normalized ratio (INR) is < 1.5 (or an in range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control

I am 18 years old or older.

Hemoglobin (HGB) ≥ 9 g/dL

Exclusion Criteria

You are currently breastfeeding.

My cancer has spread to my liver.

My LMS came back within 6 months after my last gemcitabine dose.

Treatment Details

Interventions

• Cytoreductive Surgery (Surgery)
• Dacarbazine (Alkylating agents)
• Gemcitabine (Other)

Trial Overview The study tests if heated chemotherapy given in the abdomen right after surgery can prevent uterine leiomyosarcoma from returning. Participants undergo cytoreductive surgery followed by HIPEC with Gemcitabine plus Dacarbazine chemotherapy. Their condition is monitored using FACT G questionnaires and imaging scans like CT or MRI with Gadolinium contrast.

Participant Groups

Group I: Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine Experimental Treatment 6 Interventions

* 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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Kristen Ganjoo

Lead Sponsor

Trials

3

Recruited

80+