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.
AC Camargo Cancer Center
178 participants
Dec 22, 2017
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- Previous hysterectomy in other institution
- Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)
- Previous pelvic node dissection
Interventions
At least one sentinel node should be retrieved in both hemipelvis. If no sentinel node is found in one hemipelvis, a side specific lymphadenectomy will be performed.
Systematic Pelvic and Para-Aortic Lymphadenectomy
Locations(5)
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NCT03366051