Informations générales (source: ClinicalTrials.gov)
Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS (BFR-ESS)
Interventional
Phase 2
Centre Leon Berard (Voir sur ClinicalTrials)
janvier 2019
janvier 2028
29 juin 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:48 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Patricia PAUTIER | 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 | |||||
| IFSI COCHIN-LA ROCHEFOUCAULT (AP-HP) | ALEXANDRE Jérôme | 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 Antoine Lacassagne - 06189 - Nice - France | Esma SAADA-BOUZID | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Sabine NOAL, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | GUILLEMET Cécile | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63000 - Clermont-Ferrand - France | Pascale DUBRAY-LONGERAS | Contact (sur clinicalTrials) | |||
| CHU Dupuytren - Limoges - France | VENAT-BOUVET Laurence | Contact (sur clinicalTrials) | |||
| CHU Tours - 37044 - Tours - France | Hélène VEGAS | Contact (sur clinicalTrials) | |||
| Hopital La Timone - 13005 - Marseille - France | Florence DUFFAUD, MD | Contact (sur clinicalTrials) | |||
| ICO Centre René Gauducheau - 44805 - Saint-Herblain - France | Emmanuelle BOMPAS | Contact (sur clinicalTrials) | |||
| Insitut Bergonié - Bordeaux - France | FLOQUET Anne | Contact (sur clinicalTrials) | |||
| Institut Godinot - Reims - France | SAVOYE Aude-Marie | 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 Léon Bérard - 69373 - Lyon - France | Isabelle RAY-COQUARD, MD PhD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59000 - Lille - France | Nicolas PENEL, MD | Contact (sur clinicalTrials) | |||
| CHU Besançon - 25030 - Besançon - France | Loic CHAIGNEAU, MD | Contact (sur clinicalTrials) | |||
| CHUSE - Saint-Priest-en-Jarez - France | FOURNEL Pierre, MD | Contact (sur clinicalTrials) | |||
| Hopital Pitié Salpétrière - 75013 - Paris - France | Jean-Philippe SPANO | Contact (sur clinicalTrials) | |||
| Hopital Privé de la Loire - 42020 - Saint-Étienne - France | Olivier COLLARD, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Montpellier - 34298 - Montpellier - France | Michel FABBRO | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmette - Marseille - France | BERTUCCI François | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- 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≥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.
- 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.