RecruitingPhase 2NCT03624244

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


Sponsor

Centre Leon Berard

Enrollment

40 participants

Start Date

Jan 23, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether women with low-grade endometrial stromal sarcoma (a rare type of slow-growing uterine cancer) who have been successfully controlled on hormone-blocking drugs for at least 2–3 years should continue those drugs or can safely stop them. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with low-grade endometrial stromal sarcoma - Your cancer is locally advanced, has spread to other areas, or spread during your original surgery - You have been on aromatase inhibitor therapy (such as anastrozole, exemestane, or letrozole) for at least 24–36 months - Your disease is currently controlled (stable or responding) on this therapy **You may NOT be eligible if...** - You have been on hormone-blocking therapy for less than the required duration - Your cancer is currently growing while on treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAromatase Inhibitors

Maintenance of AI versus interruption of AI


Locations(22)

CHU Besançon

Besançon, France

Insitut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Oscar Lambret

Lille, France

CHU Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

Hopital La Timone

Marseille, France

Hopital La Timone

Marseille, France

Institut Paoli Calmette

Marseille, France

Institut de Cancérologie de Montpellier

Montpellier, France

Centre Antoine Lacassagne

Nice, France

Hopital Pitié Salpétrière

Paris, France

AP-HP Hopîtal Cochin

Paris, France

Insitut Curie

Paris, France

Institut Godinot

Reims, France

Centre Henri Becquerel

Rouen, France

Hopital Privé de la Loire

Saint-Etienne, France

ICO Centre René Gauducheau

Saint-Herblain, France

CHUSE

Saint-Priest-en-Jarez, France

CHU Tours

Tours, France

Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT03624244