Clinical trial · Interventional
Sentinel Node Mapping in High Risk Endometrial Cancer
Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.
NCT03366051CI-TRIAL-00079265ALICEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Lymph Node Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphadenectomy | Procedure | — | UNRESOLVED |
| Sentinel Node Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sentinel Node Mapping plus Lymphadenectomy
- description
- Patients with high risk endometrial cancer will undergo Sentinel Node Mapping followed by Systematic Pelvic and Para-Aortic Lymphadenectomy
- interventionNames
- Procedure: Sentinel Node Mapping
- Procedure: Lymphadenectomy
- type
- EXPERIMENTAL
- label
- Sentinel Node Mapping
- description
- Patients with high risk endometrial cancer will undergo Sentinel Node Mapping per NCCN algorithm
- interventionNames
- Procedure: Sentinel Node Mapping
Primary outcomes (1)
- measure
- Recurrence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * High grade histologies (endometrioid grade 3, serous, clear cell and carcinosarcoma) * Endometrioid grades 1 or 2 with myometrial invasion of ≥50% * Endometrioid grades 1 or 2 with cervical invasion * Clinically suitable to receive systematic lymphadenectomy * Consent statement Exclusion Criteria: * Previous hysterectomy in other institution * Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis) * Previous pelvic node dissection
References
Publications (9)
- BACKGROUNDBaiocchi G, Mantoan H, Kumagai LY, Goncalves BT, Badiglian-Filho L, de Oliveira Menezes AN, Faloppa CC, De Brot L, da Costa AABA. The Impact of Sentinel Node-Mapping in Staging High-Risk Endometrial Cancer. Ann Surg Oncol. 2017 Dec;24(13):3981-3987. doi: 10.1245/s10434-017-6132-8. Epub 2017 Oct 20. PMID 29058141
- BACKGROUNDHolloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28. PMID 28566221
- BACKGROUNDHolloway RW, Gupta S, Stavitzski NM, Zhu X, Takimoto EL, Gubbi A, Bigsby GE, Brudie LA, Kendrick JE, Ahmad S. Sentinel lymph node mapping with staging lymphadenectomy for patients with endometrial cancer increases the detection of metastasis. Gynecol Oncol. 2016 May;141(2):206-210. doi: 10.1016/j.ygyno.2016.02.018. Epub 2016 Mar 2. PMID 26905211
- BACKGROUNDSoliman PT, Westin SN, Dioun S, Sun CC, Euscher E, Munsell MF, Fleming ND, Levenback C, Frumovitz M, Ramirez PT, Lu KH. A prospective validation study of sentinel lymph node mapping for high-risk endometrial cancer. Gynecol Oncol. 2017 Aug;146(2):234-239. doi: 10.1016/j.ygyno.2017.05.016. Epub 2017 May 18. PMID 28528918
- BACKGROUNDRossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1. PMID 28159465
- BACKGROUNDBodurtha Smith AJ, Fader AN, Tanner EJ. Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 May;216(5):459-476.e10. doi: 10.1016/j.ajog.2016.11.1033. Epub 2016 Nov 18.