Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03624244 En recrutement IDF

Titre

Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS

Type

Interventional

Pathologie

Sarcomes
Sarcome du stroma endométrial
Tumeurs du stroma endométrial

Phase

Phase 2

Promoteur

Centre Leon Berard (Voir sur ClinicalTrials)

Date de début

janvier 2019

Date de fin

janvier 2031

Dernière mise à jour

02 mars 2026

Résumé

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).

Détail

Voir le détail Uterine sarcomas are rare tumors with an incidence of 1.7/100 000 women per year, including 20% of endometrial stromal sarcomas (ESS). Patients with low grade ESS (LGESS) have a good prognosis with a 5-year overall survival rates ranging from 66 to 98%, depending on the stage of the disease. Majority of LGESS report estrogen receptor (ER) and/or progesterone receptor positive and a chromosomal translocation with JAZF1-SUZ12. Based on the current European Society of Medical Oncology (ESMO)guidelines, the standard treatment for patients with early/non metastatic ESS is total hysterectomy plus or less bilateral salpingo-oophorectomy. The use of hormonal therapy (HT) for advanced or metastatic disease is recommended based on retrospective data from small series providing evidence that HT have an anti-tumor activity on LGESS. HT includes aromatase inhibitors (AI), progestins and gonadotrophin-releasing hormone. Very few data are available in this rare disease, but retrospective analyses show that AI may provide response rates of 46 to 67% in metastatic LGESS patients (7% complete response, 60% partial response), with a mean duration of response of 24 months. Even if AI are effective and well tolerated, chronical mild to moderate (grade 1-2) side-effects (arthritis, hot-flashes, osteoporosis, hypercholesterolemia, cardiac events) have a negative impact on patient's well-being because of the treatment long term duration and need to be balanced in such long term survival. To date, the question of the optimal duration of HT in LGESS is still pending. The investigator propose an open-label, randomized, multicenter phase II study aiming at determining the feasibility of interruption of AI in patients with locally advanced or metastatic LGESS after long term stabilization or response to AI. The study will use a sequential bayesian design allowing for continuous monitoring of the main efficacy outcome, thus leading to a smaller more informative trial, and specifically tied to decision making. This design is particularly suited to characterize efficacy signals in the context of a very rare pathology. Moreover JAZF1-JJAZ1 fusion gene is not identified in all LGESS. Ancillary studies will provide precious data aiming at: - Identifying predictive factors of prolonged response to HT or late resistance (Next Generation Sequencing and Comparative Genome Hybridization). - Evaluating sociobehavioral (only for French sites) of patients by following questionnaire: Zimbardo Time Perspective Inventory (ZTPI) , Functional, Communicative and Critical Health Literacy/ 14-item Health Literacy Scale (FCCHL/HLS14), VICAN, Fear of Cancer Recurrence (FCR) and Patient-Generated Index (PGI). Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT CURIE		En recrutement IDF	10/04/2025 13:12:17	Contacter
CLCC INSTITUT GUSTAVE ROUSSY	Patricia PAUTIER	En recrutement IDF	10/04/2024 12:28:37	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Cochin	ALEXANDRE Jérôme			Contact (sur clinicalTrials)
INSTITUT GUSTAVE ROUSSY	Patricia PAUTIER, MD			Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Jean Perrin - 63000 - Clermont-Ferrand 3024635 - France	Pascale DUBRAY-LONGERAS			Contact (sur clinicalTrials)
Centre Léon Bérard - 69373 - Lyon 2996944 - France	Isabelle RAY-COQUARD, MD PhD			Contact (sur clinicalTrials)
CHU Besançon - 25030 - Besançon 3033123 - France	Laura MANSI, MD			Contact (sur clinicalTrials)
ICO Centre René Gauducheau - 44805 - Saint-Herblain 2979590 - France	Emmanuelle BOMPAS			Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Antoine Lacassagne - 06189 - Nice 2990440 - France	Esma SAADA-BOUZID			Contact (sur clinicalTrials)
Centre François Baclesse - 14076 - Caen 3029241 - France	Sabine NOAL, MD			Contact (sur clinicalTrials)
Centre Henri Becquerel - Rouen 2982652 - France	GUILLEMET Cécile			Contact (sur clinicalTrials)
Centre Oscar Lambret - 59000 - Lille 2998324 - France	Nicolas PENEL, MD			Contact (sur clinicalTrials)
CHU Dupuytren - Limoges 2998286 - France	VENAT-BOUVET Laurence			Contact (sur clinicalTrials)
CHU Tours - 37044 - Tours 2972191 - France	Hélène VEGAS			Contact (sur clinicalTrials)
CHUSE - Saint-Priest-en-Jarez 2977350 - France	FOURNEL Pierre, MD			Contact (sur clinicalTrials)
Hopital La Timone - 13005 - Marseille 2995469 - France	Florence DUFFAUD, MD			Contact (sur clinicalTrials)
Hopital Pitié Salpétrière - 75013 - Paris 2988507 - France	Jean-Philippe SPANO			Contact (sur clinicalTrials)
Hopital Privé de la Loire - 42020 - Saint-Etienne 2980291 - France	Olivier COLLARD, MD			Contact (sur clinicalTrials)
Insitut Bergonié - Bordeaux 3031582 - France	FLOQUET Anne			Contact (sur clinicalTrials)
Insitut Curie - Paris 2988507 - France	WATSON Sarah, MD			Contact (sur clinicalTrials)
Institut de Cancérologie de Montpellier - 34298 - Montpellier 2992166 - France	Stanislas QUESADA			Contact (sur clinicalTrials)
Institut Godinot - Reims 2984114 - France	SAVOYE Aude-Marie			Contact (sur clinicalTrials)
Institut Paoli Calmette - Marseille 2995469 - France	BERTUCCI François			Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'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 Criteria:

Critère de non inclusion

- 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.

NCT03624244 - Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS

Informations générales
Etablissements
Critères
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