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

Who is this study for? Patients with Low Grade Endometrial Stromal Sarcoma
What treatments are being studied? Aromatase Inhibitors
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Besançon
RECRUITING
Besançon
Insitut Bergonié
RECRUITING
Bordeaux
Centre François Baclesse
RECRUITING
Caen
Centre Jean Perrin
RECRUITING
Clermont-ferrand
Centre Oscar Lambret
RECRUITING
Lille
CHU Dupuytren
RECRUITING
Limoges
Centre Léon Bérard
RECRUITING
Lyon
Hopital La Timone
RECRUITING
Marseille
Hopital La Timone
RECRUITING
Marseille
Institut Paoli Calmette
RECRUITING
Marseille
Institut de Cancérologie de Montpellier
RECRUITING
Montpellier
Centre Antoine Lacassagne
NOT_YET_RECRUITING
Nice
AP-HP Hopîtal Cochin
RECRUITING
Paris
Hopital Pitié Salpétrière
RECRUITING
Paris
Insitut Curie
RECRUITING
Paris
Institut Godinot
RECRUITING
Reims
Centre Henri Becquerel
RECRUITING
Rouen
Hopital Privé de la Loire
RECRUITING
Saint-etienne
ICO Centre René Gauducheau
RECRUITING
Saint-herblain
CHUSE
RECRUITING
Saint-priest-en-jarez
CHU Tours
RECRUITING
Tours
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Séverine METZGER
severine.metzger@lyon.unicancer.fr
+33478782786
Backup
Isabelle RAY-COQUARD, MD PhD
isabelle.ray-coquard@lyon.unicancer.fr
+33478782828
Time Frame
Start Date: 2019-01-23
Estimated Completion Date: 2031-01
Participants
Target number of participants: 40
Treatments
Experimental: Interruption of aromatase inhibitors
Interruption of aromatase inhibitors until progression disease. At disease progression, AI can be reintroduced.
Other: Maintenance of aromatase inhibitors
Maintenance of aromatase inhibitors
Sponsors
Leads: Centre Leon Berard

This content was sourced from clinicaltrials.gov