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New treatment option for Leiomyosarcoma Uterus
Official title Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour
ClinicalTrials.gov ID: NCT06524583
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leiomyosarcoma uterus.
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
- Addition of postoperative chemotherapy to prevent or delay recurrence in patients newly diagnosed with localized uterine leiomyosarcoma and who have undergone complete tumor surgery.
- 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 to 75, women only
You may be able to join if
- Patient must have a histologically confirmed diagnosis of uterine leiomyosarcoma obtained less than 8 weeks from the surgery
- Eastern cooperative oncology group (ECOG) performance status (PS) 0 or 1
- Patient was previously untreated with chemotherapy for a sarcoma, and did not receive anthracyclines and/or trabectedin for another cancer
- Available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient quantity and quality to allow CINSARC NanoCind® qualification (low-risk...
- Age ≥ 18 years and ≤ 75 years
You likely can't join if
- Exclusion criteria:
- All other histology types of uterine sarcoma (adenosarcoma, endometrial sarcoma, undifferentiated uterine sarcoma)
- Prior or concurrent malignant disease diagnosed or treated in the last 5 years except for adequately treated in situ carcinoma of the cervix, basal...
- Planned pelvic post-operative radiation therapy
- Metastatic or measurable disease on CT-Scan
- Known hypersensitivity to doxorubicin or trabectedin or to any of the excipients
See the full eligibility criteria
- Patient must have a histologically confirmed diagnosis of uterine leiomyosarcoma obtained less than 8 weeks from the surgery
- Eastern cooperative oncology group (ECOG) performance status (PS) 0 or 1
- Patient was previously untreated with chemotherapy for a sarcoma, and did not receive anthracyclines and/or trabectedin for another cancer
- Available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient quantity and quality to allow CINSARC NanoCind® qualification (low-risk or high-risk)
- Age ≥ 18 years and ≤ 75 years
- FIGO 2018 classification stage I (IA and IB), with complete resection (total hysterectomy and optional bilateral oophorectomy; possible ovarian preservation is feasible in selected cases)
- No measurable disease, as assessed by the investigator: normal post-operative thoracic, abdominal and pelvic CT-scan or normal MRI of abdomen and pelvis + normal chest CT performed within 4 weeks prior to inclusion or...
- Signed informed consent form prior to any trial specific procedures consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation
- Patient must be affiliated to a social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials). Additional for randomization
- checked at study entry are all still met at the time of randomization
- High-risk CINSARC signature
- Patient must have a diagnosis of uterine leiomyosarcoma confirmed by a local sarcoma expert pathologist from RRePS (Sarcoma Pathology Reference Network from NETSARC +) locally or by the study central RRePS expert...
- Adequate hematologic organ function:
- absolute neutrophil count ≥ 1.5 Giga/ L
- hemoglobin ≥ 9 g/dL
- platelets ≥ 100 Giga/L
- Adequate renal function: serum creatinine ≤ 1.5 mg/dL (≤ 132.6 µmol/L) or calculated creatinine clearance ≥60 mL/min (by the Cockcroft and Gault formula)
- Adequate liver function: total bilirubin ≤ upper limit of normal (ULN), transaminases ≤ 2.5 x ULN, alkaline phosphatases ≤ 1.5 x ULN
- Adequate cardiac function: cardiac ultrasound and/or isotopic ventriculography, shortening fraction (SF) \> 30%, Left Ventricular Ejection Fraction (LVEF) (per ultrasound or scintigraphy) \> 50%
- Creatine phosphokinase (CPK) ≤ 2,5 x ULN
- Albumin ≥ 25 g/L
- Signed informed consent form for the assigned by chance phase, consistent with ICH-GCP and local legislation.
- Exclusion criteria:
- All other histology types of uterine sarcoma (adenosarcoma, endometrial sarcoma, undifferentiated uterine sarcoma)
- Prior or concurrent malignant disease diagnosed or treated in the last 5 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell...
- Planned pelvic post-operative radiation therapy
- Metastatic or measurable disease on CT-Scan
- Known hypersensitivity to doxorubicin or trabectedin or to any of the excipients
- Any contra-indication for the use of doxorubicin and/or trabectedin treatment
- Participation in another therapeutic trial within the 30 days prior to inclusion in the study
- Active viral hepatitis B or C or known human immunodeficiency virus (HIV) infection.
- Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) or other investigational agents within the last 4 weeks (6 weeks for nitrosoureas and mitomycin C)
- Cardiovascular dysfunction:
- Congestive heart failure (New York Heart Association [NYHA]) ≥ 2)
- Myocardial infarction \<6 months before study
- Poorly controlled cardiac arrhythmias
- Uncontrolled hypertension
- Unstable (angina symptoms at rest) or new-onset angina (begun within the last 3 months) 11. Ongoing infection \> Grade 2 according to NCI-CTCAE v5.0 12. Breastfeeding woman 13. Patients unwilling or unable to comply...
- Patient must have a diagnosis of uterine leiomyosarcoma confirmed by a sarcoma expert pathologist or by the study central pathologist
- Patients with a low-risk CINSARC signature
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Besançon, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nice, France
- Paris, France
- Poitiers, France
- Rennes, France
- Rouen, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Tours, France
- Vandœuvre-lès-Nancy, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Besançon, France; Bordeaux, France; Caen, France; Clermont-Ferrand, France; Dijon, France and 14 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.