Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524583
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief 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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interest of Adjuvant Chemotherapy in Patients With CINSARC High-risk Localized Resected Uterine Leiomyosarcoma - Sarcome 15
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
L-UteCIN
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 ie standard treatment active post-surgical surveillance or chemotherapy with a 11 randomization on one factor morcellation versus no morcellation of uterine tumor
LOW-RISK LR CINSARC patients data will be prospectively collected
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 ie standard treatment active post-surgical surveillance or chemotherapy with a 11 randomization on one factor morcellation versus no morcellation of uterine tumor
LOW-RISK LR CINSARC patients data will be prospectively collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None