Actively Recruiting
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
Led by UNICANCER · Updated on 2025-03-30
198
Participants Needed
25
Research Sites
304 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
P
PharmaMar
Collaborating Sponsor
AI-Summary
What this Trial Is About
Addition of postoperative chemotherapy to prevent or delay recurrence in patients newly diagnosed with localized uterine leiomyosarcoma and who have undergone complete tumor surgery.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed uterine leiomyosarcoma diagnosis within 8 weeks after surgery
- ECOG performance status 0 or 1
- No prior chemotherapy for sarcoma and no previous anthracyclines or trabectedin for other cancers
- Available tumor tissue suitable for CINSARC NanoCind® testing
- Age between 18 and 75 years
- FIGO 2018 stage I uterine leiomyosarcoma with complete tumor resection
- No measurable disease confirmed by imaging within 4 weeks prior to study entry
- Signed informed consent in line with ICH-GCP and local laws
- Affiliated with social security or equivalent health insurance
- For randomization: all above criteria still met
- High-risk CINSARC signature
- Diagnosis confirmed by local or central sarcoma expert pathologist
- Adequate blood counts: neutrophils ≥1.5 G/L, hemoglobin ≥9 g/dL, platelets ≥100 G/L
- Adequate kidney function: creatinine ≤1.5 mg/dL or clearance ≥60 mL/min
- Adequate liver function: bilirubin ≤ULN, transaminases ≤2.5x ULN, alkaline phosphatase ≤1.5x ULN
- Adequate heart function: shortening fraction >30%, left ventricular ejection fraction >50%
- Creatine phosphokinase ≤2.5x ULN
- Albumin ≥25 g/L
- Signed informed consent for randomized phase
You will not qualify if you...
- Other uterine sarcoma types (adenosarcoma, endometrial sarcoma, undifferentiated sarcoma)
- Malignancy diagnosed or treated in past 5 years except certain in situ or skin cancers
- Planned pelvic post-operative radiation therapy
- Metastatic or measurable disease on CT scan
- Known allergy to doxorubicin, trabectedin, or their components
- Contraindications to doxorubicin or trabectedin use
- Participation in another therapeutic trial within 30 days before study
- Active hepatitis B or C or HIV infection
- Anticancer therapy within last 4 weeks (6 weeks for nitrosoureas and mitomycin C)
- Significant cardiovascular issues including congestive heart failure NYHA ≥2, recent myocardial infarction, uncontrolled arrhythmias or hypertension, unstable angina
- Active infection above Grade 2 severity
- Breastfeeding women
- Inability or unwillingness to comply with study procedures due to personal reasons
- Persons under legal custody or guardianship
- For randomization: unknown CINSARC risk, failure to confirm diagnosis centrally, more than 13 weeks since surgery, or use of specific medications or vaccines prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Institut de Cancerologie de L'Ouest (Ico)
Angers, France, 49100
Not Yet Recruiting
2
Hopital Jean Minjoz
Besançon, France, 25030
Not Yet Recruiting
3
Institut Bergonie
Bordeaux, France, 33076
Not Yet Recruiting
4
Centre Francois Baclesse
Caen, France, 14176
Not Yet Recruiting
5
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
6
Centre Georges Francois Leclerc
Dijon, France, 21079
Not Yet Recruiting
7
Chu Limoges
Limoges, France, 87042
Not Yet Recruiting
8
Centre Léon Berard
Lyon, France, 69373
Not Yet Recruiting
9
Institut Paoli Calmettes
Marseille, France, 13273
Not Yet Recruiting
10
La Timone University Hospital
Marseille, France, 13385
Actively Recruiting
11
Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
12
Hopital Saint Louis
Paris, France, 75010
Not Yet Recruiting
13
Hôpital Cochin
Paris, France, 75014
Not Yet Recruiting
14
Groupe Hospitalier Diaconesses Croix St Simon
Paris, France, 75020
Not Yet Recruiting
15
Hopital Tenon
Paris, France, 75020
Not Yet Recruiting
16
Institut Curie
Paris, France
Not Yet Recruiting
17
Chu de Poitiers
Poitiers, France, 86000
Not Yet Recruiting
18
Centre Eugene Marquis
Rennes, France, 35042
Not Yet Recruiting
19
Centre Henri Becquerel
Rouen, France, 76038
Not Yet Recruiting
20
Institut de cancerologie de l'ouest site Rene Gauducheau
Saint-Herblain, France, 44805
Not Yet Recruiting
21
Institut de Cancerologie Strasbourg Europe (Icans)
Strasbourg, France
Not Yet Recruiting
22
Institut Claudius Regaud
Toulouse, France, 31052
Not Yet Recruiting
23
CHU Bretonneau
Tours, France, 37000
Not Yet Recruiting
24
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54519
Not Yet Recruiting
25
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
A
Amel MEKALICHE, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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