Comparing treatment strategies for low grade endometrial stromal sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the clinical impact of interrupting versus maintaining aromatase inhibitors in patients with locally advanced or metastatic low grade endometrial stromal sarcoma (LGESS). The primary goal is to compare progression-free survival (PFS) between these two treatment strategies. Patients will be randomized to either continue or stop their aromatase inhibitor therapy after a specified duration, with the aim of assessing the effects on disease progression and overall patient well-being. The study is designed to provide insights into the optimal management of LGESS, a rare tumor type with limited treatment data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥18 years;
* Histological confirmation of low grade ESS;
* Locally advanced or metastatic disease at diagnosis or patient experiencing a tumor effraction during hysterectomy;
* Treatment with aromatase inhibitors (Anastrozole or Exemestane or Letrozole ) initiated either: for at least 24 months (in patients with no residual disease or non-measurable disease at the last AI initiation) OR for at least 36 months (in patients with measurable disease at the last AI initiation);
* Disease must be controlled at the time of the randomisation (objective response or stable disease) by the aromatase inhibitor initiated either for at least 24 or 36 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
* Covered by a medical insurance;
* Signed informed consent prior to any study-specific procedure.

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* Patient concurrently using other approved or investigational antineoplastic agents;
* Major concurrent disease affecting cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
* Prior history of malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;
* Patients using prohibited concomitant and/or concurrent medications
* Contra-indication according to SmPCs.
* Patient requiring tutorship or curatorship.

Where it's running

• CHU Besançon
  Besançon, France Recruiting
• Insitut Bergonié
  Bordeaux, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• Centre Jean Perrin
  Clermont-Ferrand, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• CHU Dupuytren
  Limoges, France Recruiting

Study contacts

• Principal investigator: Isabelle RAY-COQUARD, MD PhD — Centre Leon Berard
• Study coordinator: Séverine METZGER
• Email: severine.metzger@lyon.unicancer.fr
• Phone: +33478782786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.