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Comparing treatment strategies for low grade endometrial stromal sarcoma

Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS

Phase 2 Interventional Centre Leon Berard · NCT03624244

This study is testing whether stopping or continuing a specific hormone therapy helps people with low grade endometrial stromal sarcoma live longer without their cancer getting worse.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years and up
SexFemale
SponsorCentre Leon Berard Academic / other
Locations22 sites (Besançon and 21 other locations)
Trial IDNCT03624244 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed low grade endometrial stromal sarcoma who have been treated with aromatase inhibitors for a specified duration.

Not a fit: Patients who are pregnant, breastfeeding, or currently using other antineoplastic agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the most effective treatment strategy for patients with low grade endometrial stromal sarcoma, potentially improving their quality of life and survival outcomes.

How similar studies have performed: While there is limited data on this specific approach, retrospective analyses suggest that aromatase inhibitors have shown promising response rates in metastatic LGESS patients, indicating potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Besançon and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Low Grade Endometrial Stromal SarcomaAromatase inhibitors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.