Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
Hospital do Cancer de Barretos
RECRUITING
Barretos
Hospital Erasto Gaertner
RECRUITING
Curitiba
AC Camargo Cancer Center
RECRUITING
São Paulo
Albert Einstein Hospital
RECRUITING
São Paulo
Sao Camilo Oncologia
RECRUITING
São Paulo
Contact Information
Primary
Bruna Goncalves, RN, MSc
bruna.goncalves@accamargo.org.br
551121895110
Time Frame
Start Date: 2017-12-22
Estimated Completion Date: 2024-12-20
Participants
Target number of participants: 178
Treatments
Active_comparator: Sentinel Node Mapping plus Lymphadenectomy
Patients with high risk endometrial cancer will undergo Sentinel Node Mapping followed by Systematic Pelvic and Para-Aortic Lymphadenectomy
Experimental: Sentinel Node Mapping
Patients with high risk endometrial cancer will undergo Sentinel Node Mapping per NCCN algorithm
Related Therapeutic Areas
Sponsors
Leads: AC Camargo Cancer Center