Interest of Adjuvant Chemotherapy in Patients With CINSARC High-risk Localized Resected Uterine Leiomyosarcoma - Sarcome 15
Overview
- Phase
- Phase 2
- Intervention
- Doxorubicin
- Conditions
- Leiomyosarcoma Uterus
- Sponsor
- UNICANCER
- Enrollment
- 198
- Locations
- 25
- Primary Endpoint
- Relapse-free survival
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Addition of postoperative chemotherapy to prevent or delay recurrence in patients newly diagnosed with localized uterine leiomyosarcoma and who have undergone complete tumor surgery.
Detailed Description
This is a biological driven study comprising: * a multicenter, randomized and comparative phase II trial designed to demonstrate whether adding 4 cycles of post-operative chemotherapy improves relapse-free survival as compared with follow-up (standard management) in patients with resected FIGO stage I uterine leiomyosarcoma, considered at high-risk according to CINSARC NanoCind® signature. * a prospective cohort for patients with resected FIGO stage I uterine leiomyosarcoma, considered at low-risk according to CINSARC NanoCind® signature. HIGH-RISK (HR) CINSARC patients will be randomized post-operatively between the two arms of treatment, i.e. standard treatment (active post-surgical surveillance) or chemotherapy, with a 1:1 randomization on one factor: morcellation versus no morcellation of uterine tumor. LOW-RISK (LR) CINSARC patients' data will be prospectively collected
Investigators
Eligibility Criteria
Inclusion 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 randomization in the study
- •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 inclusion criteria for randomization
Exclusion Criteria
- •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 carcinoma
- •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)
Arms & Interventions
Arm B
Experimental treatment: 4 cycle of Doxorubicine + trabectedin
Intervention: Doxorubicin
Arm B
Experimental treatment: 4 cycle of Doxorubicine + trabectedin
Intervention: Trabectedin
Outcomes
Primary Outcomes
Relapse-free survival
Time Frame: From randomization or enrollment to disease recurrence or death, up to 5 years
The relapse-free survival is defined as the time from the date of randomization assignment (or the date of enrollment for patients in the prospective cohort) to the date of first disease recurrence/relapse (local/regional recurrence and/or distant metastasis) or death from any cause whichever comes first.
Secondary Outcomes
- Incidence of adverse events(Throughout study completion, up to 5 years)
- Overall survival(From randomization or enrollment to death, up to 5 years)
- Metastases-free survival(From randomization or enrollment to metastases onset or death, up to 5 years)
- Quality of life questionnaire - Core 30 (QLQ-C30)(At baseline, end of treatment (up to week 12), 4 months, 6 months, 1 year and 2 years)