Study on Surgery and Heated Chemotherapy with Gemcitabine and Dacarbazine for Uterine Leiomyosarcoma

Sponsor: Kristen Ganjoo

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04727242

Provider View

This clinical trial is exploring whether using heated chemotherapy in the abdomen right after surgery can help reduce the chances of uterine leiomyosarcoma, a type of cancer, coming back.

Patient Parameters

Program Overview

The aim of this study is to see if a treatment involving surgery to remove uterine leiomyosarcoma, followed by a dose of heated chemotherapy directly in the abdomen, can lower the risk of the cancer returning. The chemotherapy drugs used are gemcitabine and dacarbazine. Researchers will also look at the safety of this approach and how it affects patients' quality of life over time.

Description

The main goal of this study is to find out how effective it is to use surgery combined with heated chemotherapy (HIPEC) using gemcitabine, followed by regular chemotherapy with dacarbazine, in treating uterine leiomyosarcoma that has come back in the same area.

Researchers will also check how safe this treatment is and how it affects patients' quality of life before and after the treatment. They will measure how long patients stay free from cancer in the abdomen at 6 and 12 months after treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with uterine leiomyosarcoma that has come back in the same area.
  • Imaging tests show the cancer has returned locally.
  • Suitable for surgery to remove as much of the cancer as possible, as decided by the doctor.
  • Aged 18 years or older.
  • Expected to live more than 3 months.
  • Women who can have children must have a negative pregnancy test within 7 days before surgery, unless they are postmenopausal.
  • In good general health with an ECOG performance status of 0 to 2.
  • Blood tests showing:
    • Hemoglobin level of at least 9 g/dL.
    • White blood cell count of at least 3.0 K/ul.
    • Neutrophil count of at least 1.5 K/ul.
    • Platelet count of at least 100 K/ul.
    • Normal bilirubin levels.
    • Liver enzymes (SGOT/SGPT) less than 2.5 times the normal limit.
    • Creatinine level less than 1.5 times the normal limit or creatinine clearance over 60 mL/min.
    • Blood clotting times within normal range.
    • Serum albumin level of at least 2.5 g/dL.
  • Able to understand and willing to sign the consent form.

Exclusion Criteria

  • Cancer returned less than 6 months after the last gemcitabine treatment.
  • Active cancer outside the abdomen, including fluid around the lungs, unless successfully treated.
  • Previous gemcitabine treatment not given as part of initial therapy.
  • Previous treatment with dacarbazine.
  • Active infection needing antibiotics.
  • Unresolved side effects from previous treatments, except hair loss.
  • Pregnant or breastfeeding.
  • Cancer spread to the liver.

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