Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02598219
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2015-11-03
Brief Title:
Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Randomized Study Comparing Sentinel Node SN Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENTIRAD
Brief Summary:
The aim of this study is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence by comparing the sentinel node policy to current initial staging protocols
Detailed Description:
1 Routine exams required for diagnosis
Endometrioid biopsy or product of a dilatation-curettage under hysteroscopy for diagnosis of histologic typing
Tumor assessment Lombopelvic MRI 15 or 3T with gadolinium injection studied by steady and dynamic sequences US and CT-Scan in case of intolerance to MRI should be discussed FDG-PET may be an option
2 Tumor board The completed chart will be reviewed to confirm the risk group and indication
3 Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient
4 Informed and signed consent form
5 Study baseline assessment
Then
6 Surgery should be performed within a maximum of 4 weeks from the first consultation according arm allocated
Arm A Sentinel node policy
Arm B
Bilateral pelvic lymphadenectomy intermediate risk endometrioid
Or Ilio-infrarenal paraaortic lymphadenectomy high risk endometrioid
Or Pelvic paraaortic lymphadenectomies high risk non endometrioid
along with a peritoneal staging for each arm cytology random biopsies infracolic omentectomy
7 Second tumor board after definitive pathological results of the hysterectomy-annexectomy and node sentinel or not specimens
Endometrioid biopsy or product of a dilatation-curettage under hysteroscopy for diagnosis of histologic typing
Tumor assessment Lombopelvic MRI 15 or 3T with gadolinium injection studied by steady and dynamic sequences US and CT-Scan in case of intolerance to MRI should be discussed FDG-PET may be an option
2 Tumor board The completed chart will be reviewed to confirm the risk group and indication
3 Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient
4 Informed and signed consent form
5 Study baseline assessment
Then
6 Surgery should be performed within a maximum of 4 weeks from the first consultation according arm allocated
Arm A Sentinel node policy
Arm B
Bilateral pelvic lymphadenectomy intermediate risk endometrioid
Or Ilio-infrarenal paraaortic lymphadenectomy high risk endometrioid
Or Pelvic paraaortic lymphadenectomies high risk non endometrioid
along with a peritoneal staging for each arm cytology random biopsies infracolic omentectomy
7 Second tumor board after definitive pathological results of the hysterectomy-annexectomy and node sentinel or not specimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None