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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Active, not recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Active, not recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Hôpital privé de la Loire Coordinator of this site? Confirm its status | Saint-Etienne | France | Active, not recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | Saint-Herblain Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.