What side effects are associated with this type of intervention?

Common treatments for Leiomyosarcoma, particularly those involving cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC), can have significant side effects. These include hematologic toxicities like neutropenia, anemia, and thrombocytopenia, as well as non-hematologic toxicities such as fatigue, nausea, vomiting, diarrhea, and infection risk. Surgical complications may also occur, including pain, bleeding, and potential organ damage.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Leiomyosarcoma (LMS), particularly in advanced or metastatic stages. Doxorubicin, often used in combination with ifosfamide, is a standard chemotherapy regimen for LMS. Eribulin has also been approved for patients with advanced LMS, showing improved overall survival compared to dacarbazine. While HIPEC itself is not specifically FDA-approved for LMS, the concept of using cytotoxic agents like doxorubicin and mitomycin C in a heated intraperitoneal setting is being explored in clinical trials for its potential benefits in reducing residual cancer cells post-surgery.

What other types of research exist?

Promising novel alternatives to HIPEC for Leiomyosarcoma patients include: 1) Neoadjuvant histotype-driven chemotherapy, which tailors treatment based on the specific histological subtype of the sarcoma. 2) Regional hyperthermia combined with systemic chemotherapy, which has shown benefits in European trials for large high-grade tumors or initially unresectable disease. 3) Targeted therapies and immunotherapies, which are being explored in various clinical trials and may offer new avenues for treatment.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

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.