Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation

Endometrial Cancer Clinical Trial

Official title:

Surgical Staging for the Treatment of Endometrial Cancer Based on IOC

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02658565
• Other study ID #: MCC-15-GYN-150
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 29, 2016
• Est. completion date: November 2026

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 401
• Est. completion date: November 2026
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy.

• Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation.

• Preoperative evaluation to rule-out extra-uterine disease may include CT scan, MRI, or ultrasound. Preoperative imaging is not mandatory for study enrollment.

• Patients may have received prior systemic chemotherapy. Such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present disease.

• Patients must have GOG performance status 0, 1, or 2.

• Patients must have an estimated survival greater than or equal to 3 months

• Patients must have signed an approved informed consent and HIPAA authorization.

Exclusion Criteria:

• Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam.

• Patients who have received previous vaginal, pelvic, or abdominal irradiation.

• Patients who received chemotherapy directed at the present disease.

• Patients who have circumstances that will not permit completion of this study or the required follow-up.

• Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments.

• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years.

• Patients with GOG Performance Grade of 3 or 4.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• Lymphadenectomy
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Frederick R. Ueland, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).	24 months
Secondary	Progression-free survival	Progression-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)	5 years
Secondary	Disease-specific Survival	Disease-specific survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)	5 years
Secondary	Overall patient survival	Overall survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)	5 years
Secondary	Concordance between IOC and final pathology Incidence		5 years
Secondary	Perioperative morbidity and mortality	Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery .	5 years