Study on Letrozole for Uterine Leiomyosarcoma

Sponsor: GOG Foundation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05649956

Provider View

This clinical trial is testing whether the drug letrozole can help extend the time without disease progression in patients with uterine leiomyosarcoma. Participants will take 2.5 mg of letrozole daily.

Patient Parameters

Program Overview

This study is exploring the use of letrozole, a medication taken orally, to see if it can help patients with early-stage uterine leiomyosarcoma (LMS) live longer without their cancer getting worse. Patients will be randomly assigned to either receive letrozole or be observed without treatment. The main goal is to measure how long it takes for the cancer to progress.

Description

This trial is a phase II study where patients with newly diagnosed stage I or II uterine leiomyosarcoma will take letrozole (Femara) at a dose of 2.5 mg daily. Patients will be randomly placed into two groups: one group will receive letrozole, and the other will be under observation without treatment. The primary focus of the study is to determine the time it takes for the cancer to progress in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of uterine leiomyosarcoma limited to the uterus (stage 1 or 2).
  • Tumors must show estrogen receptor (ER) positivity.
  • Must have completed surgery to remove the uterus and ovaries within 12 weeks before starting the study.
  • No measurable disease within 6 weeks before starting the study.
  • Must be able to swallow pills.
  • Must be in good general health with a performance status score of 0 to 2.
  • Must have adequate blood and organ function based on specific lab tests.
  • Must be at least 18 years old.
  • Must sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Cannot have previously taken any aromatase inhibitors.
  • Cannot have mixed types of uterine sarcomas.
  • Cannot have active or uncontrolled infections.
  • Cannot have another invasive cancer or history of such within the last two years, except for certain skin cancers.
  • Cannot be pregnant or breastfeeding.
  • Cannot have participated in another drug study within 30 days before starting this study.
  • Cannot have severe health issues that would make participation unsafe, including serious liver, kidney, or digestive diseases.
  • Cannot have uncontrolled heart disease, such as recent heart attack or severe heart failure.
  • Cannot be receiving chemotherapy or radiation therapy.
  • Cannot have conditions that interfere with taking oral medication.
  • Cannot be deemed unfit for the study by the investigator.

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