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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test if heated chemotherapy immediately after surgery could reduce the risk of uterine cancer coming back.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

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

~2070

Dacarbazine

2005

Completed Phase 3

~5110