Actively Recruiting
Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
Led by Centre Leon Berard · Updated on 2026-02-17
40
Participants Needed
22
Research Sites
623 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed low grade endometrial stromal sarcoma
- Locally advanced or metastatic disease at diagnosis, or tumor effraction during hysterectomy
- Treated with aromatase inhibitors (Anastrozole, Exemestane, or Letrozole) for at least 24 months if no residual or non-measurable disease at last AI start
- Treated with aromatase inhibitors for at least 36 months if measurable disease at last AI start
- Disease controlled (objective response or stable disease) at randomization with AI treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or less
- Covered by medical insurance
- Signed informed consent prior to study procedures
You will not qualify if you...
- Pregnant or breastfeeding women
- Using other approved or investigational antineoplastic agents concurrently
- Major concurrent diseases affecting heart, liver, kidneys, blood system, or other clinically important conditions incompatible with trial participation
- Prior malignancies other than LGESS unless disease-free for at least 3 years (except certain skin cancers or cervical carcinoma in situ)
- Using prohibited concomitant or concurrent medications
- Contraindications according to SmPCs
- Patients requiring tutorship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
CHU Besançon
Besançon, France, 25030
Actively Recruiting
2
Insitut Bergonié
Bordeaux, France
Actively Recruiting
3
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
4
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Actively Recruiting
5
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
6
CHU Dupuytren
Limoges, France
Actively Recruiting
7
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
8
Hopital La Timone
Marseille, France, 13005
Actively Recruiting
9
Hopital La Timone
Marseille, France, 13005
Actively Recruiting
10
Institut Paoli Calmette
Marseille, France
Actively Recruiting
11
Institut de Cancérologie de Montpellier
Montpellier, France, 34298
Actively Recruiting
12
Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
13
Hopital Pitié Salpétrière
Paris, France, 75013
Actively Recruiting
14
AP-HP Hopîtal Cochin
Paris, France
Actively Recruiting
15
Insitut Curie
Paris, France
Actively Recruiting
16
Institut Godinot
Reims, France
Actively Recruiting
17
Centre Henri Becquerel
Rouen, France
Actively Recruiting
18
Hopital Privé de la Loire
Saint-Etienne, France, 42020
Actively Recruiting
19
ICO Centre René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
20
CHUSE
Saint-Priest-en-Jarez, France
Actively Recruiting
21
CHU Tours
Tours, France, 37044
Actively Recruiting
22
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
S
Séverine METZGER
CONTACT
I
Isabelle RAY-COQUARD, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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