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Compares treatment options for Low Grade Endometrial Stromal Sarcoma
Official title Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
ClinicalTrials.gov ID: NCT03624244
What this study is testing
What is Aromatase Inhibitors?
Aromatase Inhibitors is an investigational medicine, being studied as a potential treatment for low grade endometrial stromal sarcoma.
Also referred to as ANASTRAZOLE, ARIMIDEX, AROMASINE, EXEMESTANE, FEMARA, LETROZOLE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 must be controlled at the time of the randomisation (objective response or stable disease) by the aromatase inhibitor initiated either for at...
You likely can't join if
- 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...
- 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...
- Patients using prohibited concomitant and/or concurrent medications
- Contra-indication according to SmPCs.
See the full eligibility 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...
- 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...
- 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...
- Patients using prohibited concomitant and/or concurrent medications
- Contra-indication according to SmPCs.
- Patient requiring tutorship or curatorship.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nice, France
- Paris, France
- Reims, France
- Rouen, France
- Saint-Etienne, France
- Saint-Herblain, France
- Saint-Priest-en-Jarez, France
- Tours, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Caen, France; Clermont-Ferrand, France; Lille, France; Limoges, France and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.