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

NCT03624244 | Recruiting Phase 2

• 1 other identifier: ET17-200 BRF-ESS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 22

Brief Summary

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

Low Grade Endometrial Stromal Sarcoma

Keywords

Low Grade Endometrial Stromal Sarcoma; Aromatase inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes (7)

• Overall survival

  From date of randomization to death due to any cause, assessed up to 60 months

• Time to first subsequent chemotherapy/treatment or death

  From date of randomization to the earliest date of chemotherapy/treatment start date following study treatment discontinuation, or death due to any cause, whichever came first, assessed up to 60 months

• Objective response rate after reintroduction of AI in the experimental arm

  From the date of AI reintroduction in the experimental arm to the date of subsequent progression or date of death due to any cause, whichever came first, assessed up to 60 months

• Progression free survival after reintroduction of AI in the experimental arm

  From the date of AI reintroduction in the experimental arm to the date of subsequent progression or date of death due to any cause, whichever came first, assessed up to 60 months

• Duration of response to AI after reintroduction

  From the date of first objective response following the reintroduction of AI to the date of the first subsequent documented radiological progression or death due to any cause, whichever came first, assessed up to 60 months

Study Arms (2)

Interruption of aromatase inhibitors

EXPERIMENTAL

Interruption of aromatase inhibitors until progression disease. At disease progression, AI can be reintroduced.

Drug: Aromatase Inhibitors

Maintenance of aromatase inhibitors

OTHER

Maintenance of aromatase inhibitors

Drug: Aromatase Inhibitors

Interventions

Aromatase Inhibitors DRUG

Maintenance of AI versus interruption of AI

Also known as: ANASTRAZOLE, ARIMIDEX, AROMASINE, EXEMESTANE, FEMARA, LETROZOLE

Interruption of aromatase inhibitors; Maintenance of aromatase inhibitors

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (22)

CHU Besançon

Besançon, 25030, France

RECRUITING

Insitut Bergonié

Bordeaux, France

RECRUITING

Centre François Baclesse

Caen, 14076, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63000, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

CHU Dupuytren

Limoges, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Hopital La Timone

Marseille, 13005, France

RECRUITING

Hopital La Timone

Marseille, 13005, France

RECRUITING

Institut Paoli Calmette

Marseille, France

RECRUITING

Institut de Cancérologie de Montpellier

Montpellier, 34298, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

NOT YET RECRUITING

Hopital Pitié Salpétrière

Paris, 75013, France

RECRUITING

AP-HP Hopîtal Cochin

Paris, France

RECRUITING

Insitut Curie

Paris, France

RECRUITING

Institut Godinot

Reims, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

Hopital Privé de la Loire

Saint-Etienne, 42020, France

RECRUITING

ICO Centre René Gauducheau

Saint-Herblain, 44805, France

RECRUITING

CHUSE

Saint-Priest-en-Jarez, France

RECRUITING

CHU Tours

Tours, 37044, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Endometrial Stromal Tumors

Interventions

Aromatase Inhibitors; Anastrozole; exemestane; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Isabelle RAY-COQUARD, MD PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Séverine METZGER

CONTACT

+33478782786; severine.metzger@lyon.unicancer.fr

Isabelle RAY-COQUARD, MD PhD

CONTACT

+33478782828; isabelle.ray-coquard@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II comparative multicentre prospective randomised (1:1 ratio) open-label study

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 10, 2018
• Study Start: January 23, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (22)