NCT03624244 Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
| NCT ID | NCT03624244 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Leon Berard |
| Condition | Low Grade Endometrial Stromal Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-01-23 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2019-01-23 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Isabelle RAY-COQUARD, MD PhD
PRINCIPAL INVESTIGATOR
Centre Leon Berard
Frequently Asked Questions
Who can join the NCT03624244 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Low Grade Endometrial Stromal Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03624244 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03624244 currently recruiting?
Yes, NCT03624244 is actively recruiting participants. Contact the research team at severine.metzger@lyon.unicancer.fr for enrollment information.
Where is the NCT03624244 trial being conducted?
This trial is being conducted at Besançon, France, Bordeaux, France, Caen, France, Clermont-Ferrand, France and 11 additional locations.
Who is sponsoring the NCT03624244 clinical trial?
NCT03624244 is sponsored by Centre Leon Berard. The principal investigator is Isabelle RAY-COQUARD, MD PhD at Centre Leon Berard. The trial plans to enroll 40 participants.