Low Grade Endometrial Stromal Sarcoma Clinical Trial
— BFR-ESSOfficial title:
Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS
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).
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | January 2028 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | AP-HP Hopîtal Cochin | Paris | |
| France | Hopital Pitié Salpétrière | Paris | |
| France | Insitut Curie | Paris | |
| France | Institut Godinot | Reims | |
| France | Centre Henri Becquerel | Rouen | |
| France | Hopital Privé de la Loire | Saint-Étienne | |
| France | ICO Centre René Gauducheau | Saint-Herblain | |
| France | CHUSE | Saint-Priest-en-Jarez | |
| France | CHU Tours | Tours | |
| France | Institut Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Leon Berard |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Overall survival | Overall survival | From date of randomization to death due to any cause, assessed up to 60 months | |
| Secondary | Time to first subsequent chemotherapy/treatment or death | 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 | |
| Secondary | Objective response rate after reintroduction of AI in the experimental arm | Proportion of patients with a best overall response of Partial Response (PR) or Complete Response (CR) after AI reintroduction 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 | |
| Secondary | Progression free survival after reintroduction of AI in the experimental arm | 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 | |
| Secondary | Duration of response to AI after reintroduction | 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 | |
| Secondary | Incidence of Treatment-Emergent Adverse Events | Safety and Tolerability assessed according to the NCI-CTC AE version 5 | From date of randomization to follow-up visit Month 36 or death due to any cause, whichever came first, assessed up to 60 months | |
| Secondary | Quality of Life using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | Quality of Life using EORTC QLQ-C30 questionnaire. 64 questions related to cancer impact on health and daily activities composed this questionnaire. Each item has to be graded from 1 to 4 ( 1 = not at all; 4 = very much). More the score is high, worst the quality of life is. | Every 6 months until the 36th month for each patient |