Informations générales (source: ClinicalTrials.gov)
Interest of Adjuvant Chemotherapy in Patients With CINSARC High-risk Localized Resected Uterine Leiomyosarcoma - Sarcome 15 (L-UteCIN)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
janvier 2025
décembre 2030
01 avril 2025
Addition of postoperative chemotherapy to prevent or delay recurrence in patients newly
diagnosed with localized uterine leiomyosarcoma and who have undergone complete tumor
surgery.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Alexis Vautrin - 54519 - Vandoeuvre-les-nancy - France | Contact (sur clinicalTrials) | ||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - 14176 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel - 76038 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU Bretonneau - 37000 - Tours - France | Contact (sur clinicalTrials) | ||||
| Chu de Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Chu Limoges - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31052 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de L'Ouest (Ico) - 49100 - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut de cancerologie de l'ouest site Rene Gauducheau - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie Strasbourg Europe (Icans) - Strasbourg - France | Jean-Emmanuel KURTZ, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| La Timone University Hospital - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
1. Patient must have a histologically confirmed diagnosis of uterine leiomyosarcoma
obtained less than 8 weeks from the surgery
2. Eastern cooperative oncology group (ECOG) performance status (PS) 0 or 1
3. Patient was previously untreated with chemotherapy for a sarcoma, and did not
receive anthracyclines and/or trabectedin for another cancer
4. Available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient
quantity and quality to allow CINSARC NanoCind® qualification (low-risk or
high-risk)
5. Age ≥ 18 years and ≤ 75 years
6. 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)
7. 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 randomization in the study
8. Signed informed consent form prior to any trial specific procedures consistent with
international conference on harmonisation - good clinical practice (ICH-GCP) and
local legislation
9. 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 inclusion criteria for randomization
10. Inclusion criteria checked at study entry are all still met at the time of
randomization
11. High-risk CINSARC signature
12. 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 pathologist.
13. Adequate hematologic organ function:
- absolute neutrophil count ≥ 1.5 Giga/ L
- hemoglobin ≥ 9 g/dL
- platelets ≥ 100 Giga/L
14. 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)
15. Adequate liver function: total bilirubin ≤ upper limit of normal (ULN),
transaminases ≤ 2.5 x ULN, alkaline phosphatases ≤ 1.5 x ULN
16. Adequate cardiac function: cardiac ultrasound and/or isotopic ventriculography,
shortening fraction (SF) > 30%, Left Ventricular Ejection Fraction (LVEF) (per
ultrasound or scintigraphy) > 50%
17. Creatine phosphokinase (CPK) ≤ 2,5 x ULN
18. Albumin ≥ 25 g/L
19. Signed informed consent form for the randomized phase, consistent with ICH-GCP and
local legislation.
1. Patient must have a histologically confirmed diagnosis of uterine leiomyosarcoma
obtained less than 8 weeks from the surgery
2. Eastern cooperative oncology group (ECOG) performance status (PS) 0 or 1
3. Patient was previously untreated with chemotherapy for a sarcoma, and did not
receive anthracyclines and/or trabectedin for another cancer
4. Available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient
quantity and quality to allow CINSARC NanoCind® qualification (low-risk or
high-risk)
5. Age ≥ 18 years and ≤ 75 years
6. 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)
7. 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 randomization in the study
8. Signed informed consent form prior to any trial specific procedures consistent with
international conference on harmonisation - good clinical practice (ICH-GCP) and
local legislation
9. 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 inclusion criteria for randomization
10. Inclusion criteria checked at study entry are all still met at the time of
randomization
11. High-risk CINSARC signature
12. 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 pathologist.
13. Adequate hematologic organ function:
- absolute neutrophil count ≥ 1.5 Giga/ L
- hemoglobin ≥ 9 g/dL
- platelets ≥ 100 Giga/L
14. 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)
15. Adequate liver function: total bilirubin ≤ upper limit of normal (ULN),
transaminases ≤ 2.5 x ULN, alkaline phosphatases ≤ 1.5 x ULN
16. Adequate cardiac function: cardiac ultrasound and/or isotopic ventriculography,
shortening fraction (SF) > 30%, Left Ventricular Ejection Fraction (LVEF) (per
ultrasound or scintigraphy) > 50%
17. Creatine phosphokinase (CPK) ≤ 2,5 x ULN
18. Albumin ≥ 25 g/L
19. Signed informed consent form for the randomized phase, consistent with ICH-GCP and
local legislation.
- Exclusion criteria:
1. All other histology types of uterine sarcoma (adenosarcoma, endometrial
sarcoma, undifferentiated uterine sarcoma)
2. 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 carcinoma
3. Planned pelvic post-operative radiation therapy
4. Metastatic or measurable disease on CT-Scan
5. Known hypersensitivity to doxorubicin or trabectedin or to any of the
excipients
6. Any contra-indication for the use of doxorubicin and/or trabectedin treatment
7. Participation in another therapeutic trial within the 30 days prior to
inclusion in the study
8. Active viral hepatitis B or C or known human immunodeficiency virus (HIV)
infection.
9. 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)
10. 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 with the medical
procedures and follow-up required by the trial because of geographic, familial,
social, or psychological reasons 14. Persons deprived of their liberty or under
protective custody or guardianship.
Additional exclusion criteria for randomization 15. At least one of the exclusion
criteria check at study entry is met at the time of randomization 16. Unknown risk for
CINSARC signature 17. For patients who require a pathological review by the study central
pathologist, failure to obtain a confirmed diagnosis at randomization 18. More than 13
weeks have elapsed since the surgery procedure. 19. Patient receiving phenytoin within 88
hours prior to randomisation and or live attenuated vaccines within 14 days prior to
randomisation and or CYP3A4 inhibitors (e.g. oral ketoconazole, fluconazole, ritonavir,
clarithromycin or aprepitant) and or strong CYP3A4 inducers (e.g. rifampicin,
phenobarbital, St John's wort).
Criteria for continuing in the prospective cohort :
1. Patient must have a diagnosis of uterine leiomyosarcoma confirmed by a sarcoma
expert pathologist or by the study central pathologist
2. Patients with a low-risk CINSARC signature