Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366051
Status:
RECRUITING
Last Update Posted:
2022-02-18
First Post:
2017-12-04
Brief Title:
Sentinel Node Mapping in High Risk Endometrial Cancer
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer a Open Label Non-inferiority Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ALICE
Brief Summary:
This study will evaluate the role of systematic lymphadenectomy after sentinel node SLN mapping in high risk endometrial cancer high grade histologies or deep myometrial invasion The participants will be randomized in a non-inferiority controlled trial in 2 groups SLN mapping or SLN mapping followed by systematic lymphadenectomy
Detailed Description:
Although most patients with endometrial cancer present with early-stage disease the standard treatment still includes systematic lymph node dissection for staging Recently SLN mapping has emerged as an acceptable surgical strategy when deciding between complete lymphadenectomy and no node dissection This approach can help avoid the morbidity that is associated with a complete lymphadenectomy such as neurovascular injury lymphocyst formation and lymphedema A recent meta-analysis that included 55 studies and 4915 patients reported an overall SLN detection rate of 81 versus 50 for bilateral SLNs Moreover the use of indocyanine green increased the bilateral SLN detection rate compared with blue dye 746 vs 505 Yet the studies noted an overall sensitivity of 96 and false negative rates of less than 5 when analyzed per hemipelvis Since 2014 the National Comprehensive Cancer Network NCCN guidelines have recommended SLN mapping as an alternative option for node staging in endometrial cancer However most studies on SLN mapping have included patients who are at low risk for lymph node involvement and thus might underestimate the false negative rate Recently Soliman et al reported a series of only high-grade and deep invasive endometrial cancers for which patients underwent SLN mapping followed by pelvic and para-aortic lymph node dissection An 89 detection rate was reported suggesting that SLN mapping accurately identifies node metastases with an negative predictive value NPV of 98 and an false negative predictive value FNPV of 2 when analyzed by hemipelvises Positive nodes were found in 228 of patients 43 of isolated tumor cells and micrometastases and in 40 of cases the SLN was the only positive node Data from the investigators corroborate these findings-267 of high-risk cases had positive nodes 50 of isolated tumor cells and micrometastases and when analyzed by hemipelvis the NPV was 979 and the FNPV was 21 In 14 70 patients the SLN was the only positive node Moreover there are few publications that have compared the results of the addition of SLN mapping to lymphadenectomy alone Raimond et al compared 156 patients that had SLN mapping with 95 who had pelvic node dissection In their study SLN mapping and imuno-histochemistry IHC were performed in low- and intermediate-risk patients and the former detected metastatic node 3 times more often than complete pelvic lymphadenectomy alone 162 vs 51 p003 They had no false negatives and the IHC findings modified the adjuvant therapy in half of all cases Holloway et al compared a series of 661 patients who had undergone pelvic and para-aortic lymphadenectomy with 119 who were subjected to SLN mapping plus node dissection including 68 high-intermediate- and high-risk patients in the SLN mapping group GOG99 stratification Despite the similarity in demographics and pathological risk factors the SLN group had more LN metastases that were detected 303 vs 163 p0001 and received more adjuvant therapy 286 vs 163 p0003 The SLN was the only positive node in 18 50 of mapped cases and the false negative rate was 28The investigators recently published a series on high risk endometrial cancer and also recorded a higher pelvic node metastasis rate for the SLN mapping group 267 vs 143 p002 but no significant difference in para-aortic node metastases 135 vs 56 p012 Notably if considered only patients in whom SLNs were mapped 313 had pelvic positive nodes Despite the differences in uterine risk factors between groups 106 875 of patients in the SLN group had node metastasis that was diagnosed only after IHC Excluding these patients the SLN group would have had a node positivity rate of 173 similar to the N-SLN group 174 reinforcing the impact of IHC in the detection of node metastases Moreover the SLN group received more adjuvant chemotherapy 335 vs 48 The overall detection rate for SLNs was 853 and bilateral SLNs were observed in 60 The investigators noted an overall sensitivity of 90 a negative predictive value of 957 and a false negative predictive value of 43 Recently Touhami et al showed that the risk of non-SLN metastasis is 61 when the SLN metastasis size is 2mm and 5 for SLN metastasis of 2mm However one of the remaining uncertainties is the role of systematic lymphadenectomy after a positive SLN In other words is there any benefit in favor of systematic lymphadenectomy in a patient that already undergo adjuvant chemotherapy The investigators hypothesized that there is no disease free survival benefit in adding systematic lymphadenectomy to only sentinel node mapping and proposed a prospective randomized controlled non-inferiority trial comparing SLN mapping to SLN mapping with systematic lymphadenectomy in high risk endometrial cancer
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