Status:
COMPLETED
Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer
Lead Sponsor:
University Health Network, Toronto
Conditions:
Endometrial Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. It is estim...
Detailed Description
If the SLN can be accurately identified and the detection of metastatic lymph nodes in women with early stage high risk endometrial cancer can be improved then the majority of women could avoid a comp...
Eligibility Criteria
Inclusion
- Women with endometrial cancer with high risk histologic subtypes including grade 3 endometrioid, carcinosarcoma, serous, clear cell, undifferentiated adenocarcinoma, and and any mixed high risk histology.
- Clinical stage 1 disease- no evidence of metastatic disease beyond the uterus by physical exam or preoperative imaging if performed.
- Patients who have signed an approved informed consent.
- Patients who will undergo surgery that includes a hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparoscopy or robotic-assisted.
Exclusion
- Women with grade 1 or 2 endometrioid adenocarcinoma
- Patients with evidence of metastatic disease on preoperative imaging.
- Patients with evidence of intraperitoneal metastatic disease intraoperatively (patients with suspicious retroperitoneal lymph nodes intraoperatively will still be included).
- Patients with known allergy to iodine compounds
- Pregnant patient.
- Patients with previous retroperitoneal surgery.
- Patients with previous history of pelvic/abdominal radiation.
- Patients with recurrent endometrial cancer.
- Any patient treated with neoadjuvant chemotherapy and/or radiation.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01886066
Start Date
March 1 2012
End Date
September 1 2021
Last Update
March 15 2024
Active Locations (2)
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1
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N3M5
2
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada, M5T 2M9