Tests stopping versus continuing aromatase inhibitors in endometrial stromal sarcoma
Compares stopping or continuing aromatase inhibitors in adults with advanced low grade endometrial stromal sarcoma.
Plain-language title generated from the registry record
Registry title: Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
Key facts
- Where
- Besancon Cedex, Bordeaux, Caen Cedex 5, Clermont-Ferrand, Lille, Limoges Cedex 1, Lyon, Marseille, Montpellier Cedex 5, Nice Cedex 2, Paris, Paris Cedex 13, Reims, Rouen Cedex, Saint-Etienne, Saint-Herblain Cedex, Saint-Priest-en-Jarez, Tours Cedex 9, and Villejuif, FranceSee the 21 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT03624244, who can take part
Where in France
- CHU BesanconBesancon Cedex, FranceNo longer taking part
- Institut BergonieBordeaux, FranceNo longer taking part
- Centre Francois BaclesseCaen Cedex 5, FranceNo longer taking part
- Centre Jean PerrinClermont-Ferrand, FranceNo longer taking part
- Centre Oscar LambretLille, FranceNo longer taking part
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranceNo longer taking part
- Centre Leon BerardLyon, FranceNo longer taking part
- Centre Hospitalier Regional De MarseilleMarseille, FranceNo longer taking part
- Institut Paoli-CalmettesMarseille, FranceNo longer taking part
- Institut Regional Du Cancer De MontpellierMontpellier Cedex 5, FranceNo longer taking part
- Centre Antoine LacassagneNice Cedex 2, FranceNo longer taking part
- Assistance Publique Hopitaux de ParisParis, FranceNo longer taking part
- Institut CurieParis, FranceNo longer taking part
- Assistance Publique Hopitaux De ParisParis Cedex 13, FranceNo longer taking part
- Institut GodinotReims, FranceNo longer taking part
- Centre Henri BecquerelRouen Cedex, FranceNo longer taking part
- Hôpital privé de la LoireSaint-Etienne, FranceNo longer taking part
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceNo longer taking part
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceNo longer taking part
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranceNo longer taking part
- Institut Gustave RoussyVillejuif, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Leon Berard
- Trial code
- NCT03624244EU 2024-512629-97-00
- Record updated
- 17 February 2026
- Original description
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).Read full original descriptionShow less
Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS
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).
Inclusion: 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: 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; 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; Pregnant or breastfeeding woman; Patient concurrently using other approved or investigational antineoplastic agents; Contra-indication according to SmPCs; Patient requiring tutorship or curatorship.