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Surgery + HIPEC with Chemotherapy for Uterine Cancer

Phase 2
Recruiting
Led By Kristen N Ganjoo, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of local recurrence
Must not have
Presence of metastatic liver disease
Active infection requiring antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include reactions to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk; surgical complications; allergic reactions to Gadolinium used in imaging; and general discomfort from frequent health assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My uterine cancer has come back after treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my liver.
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I am currently taking antibiotics for an infection.
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I don't have lasting side effects from previous treatments, except for hair loss.
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I have received gemcitabine, but not as part of initial treatment.
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I have been treated with dacarbazine before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Intraabdominal relapse free survival
Overall Functional Assessment of Cancer Therapy: General (FACT G) score
Rate of Grade 4 infections

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cytoreductive Surgery+HIPEC gemcitabine+dacarbazineExperimental Treatment6 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Dacarbazine
2005
Completed Phase 3
~5350
Cytoreductive Surgery
2011
Completed Phase 2
~200
Gadolinium
2006
Completed Phase 4
~620

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Heated Intraperitoneal Chemotherapy (HIPEC) is a treatment for Leiomyosarcoma that involves the direct application of heated chemotherapy agents into the abdominal cavity immediately after surgical resection. The heat enhances the cytotoxic effects of the chemotherapy drugs, increasing their uptake by cancer cells, causing more DNA damage, and promoting apoptosis. This approach is significant for Leiomyosarcoma patients as it targets residual cancer cells that may remain post-surgery, potentially reducing the risk of recurrence and improving survival outcomes.
Effect of sequential application of hyperthermia and chemotherapy on the survival of a thermoresistant human melanoma cell line.The Temperature-Dependent Effectiveness of Platinum-Based Drugs Mitomycin-C and 5-FU during Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Colorectal Cancer Cell Lines.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,369 Total Patients Enrolled
Kristen GanjooLead Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
Kristen N Ganjoo, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Cytoreductive Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04727242 — Phase 2
Leiomyosarcoma Research Study Groups: Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Leiomyosarcoma Clinical Trial 2023: Cytoreductive Surgery Highlights & Side Effects. Trial Name: NCT04727242 — Phase 2
Cytoreductive Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04727242 — Phase 2
~2 spots leftby Jan 2025