Comparison of Nodal Staging in Endometrial Cancer

NCT ID: NCT04970368

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2023-06-13

Brief Summary

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sentinel Node Surgical Staging

Group Type: EXPERIMENTAL

Sentinel node procedure

Intervention Type: PROCEDURE

Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location

Selective Surgical Staging

Group Type: EXPERIMENTAL

Selective staging

Intervention Type: PROCEDURE

Intraoperative consultation (IOC)

Interventions

Sentinel node procedure

Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location

Intervention Type: PROCEDURE

Selective staging

Intraoperative consultation (IOC)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
• Histologically or cytologically confirmed endometrioid-type endometrial cancer confined to the uterine corpus
• No clinical evidence of extra-uterine disease on pre-operative evaluation.
• Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.
• Age ≥18 years.
• Life expectancy (estimated survival) of at least 6 months.
• AST(SGOT)/ALT(SGPT) < 3.0X upper limit of normal
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• GOG/ECOG Performance Status greater than 2
• Non-endometrioid cell type
• Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
• Previous vaginal, pelvic or abdominal irradiation
• Chemotherapy, hormone therapy or immunotherapy directed at the present disease
• Previous pelvic lymphadenectomy or retroperitoneal surgery
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
• Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition
• Patients with uncontrolled intercurrent illness
• Patients with psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Frederick R. Ueland, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Frederick R. Ueland, M.D.

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frederick Ueland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

MCC-21-GYN-210

Identifier Type: -

Identifier Source: org_study_id