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NCT03624244RecruitingPhase 2

Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
18 Jul 2018
Start date
23 Jan 2019
Primary completion date
Jan 2028
Lead sponsor
Centre Leon Berard
Diseases
Sarcoma
NCT number
NCT03624244
EU CT number
2024-512629-97-00
EudraCT number
2017-004876-71

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 23 Jan 2019 to the primary completion date, Jan 2028
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • Patients using prohibited concomitant and/or concurrent medications

Other illness

  • 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;

Other

  • Pregnant or breastfeeding woman;
  • Patient concurrently using other approved or investigational antineoplastic agents;
  • Contra-indication according to SmPCs.
  • Patient requiring tutorship or curatorship.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Besancon
Coordinator of this site? Confirm its status
Besancon CedexFranceActive, not recruiting
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centre Francois Baclesse
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Caen Cedex 5FranceActive, not recruiting
Centre Jean Perrin
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Clermont-FerrandFranceActive, not recruiting
Centre Oscar Lambret
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LilleFranceActive, not recruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Institut Curie
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceActive, not recruiting
Institut Godinot
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ReimsFranceActive, not recruiting
Centre Henri Becquerel
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Rouen CedexFranceActive, not recruiting
Hôpital privé de la Loire
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Saint-EtienneFranceActive, not recruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.