Last updated: January 3, 2024
Sponsor: Frederick R. Ueland, M.D.
Overall Status: Terminated
Phase
3
Condition
Endometrial Cancer
Endometriosis
Pelvic Cancer
Treatment
Sentinel node procedure
Selective staging
Clinical Study ID
NCT04970368
MCC-21-GYN-210
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy withpelvic and aortic lymphadenectomy
- Histologically or cytologically confirmed endometrioid-type endometrial cancerconfined 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 tostudy 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
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 ofsuspicious 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 hasthe potential to interfere with the safety or efficacy assessment of theinvestigational regimen
- Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions tocompounds of similar chemical or biologic composition
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance withstudy requirements
- Pregnant or lactating women
Study Design
Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Sentinel node procedure
Phase: 3
Study Start date:
November 05, 2021
Estimated Completion Date:
June 13, 2023
Connect with a study center
University of Kentucky
Lexington, Kentucky 40506
United StatesSite Not Available
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