A Phase III Trial Of The Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Rodabaugh, Kerry
Eligibility: https://www.clinicaltrials.gov/study/NCT05646316?term=NCT05646316&rank=1
Summary
Primary Objective
To compare the rates of lower extremity limb dysfunction (defined as a 4-point increase in GCLQ symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:
Arm 1: Sentinel lymph node mapping followed by side-specific lymphadenectomy on sides without a SLN identified according to an NCCN Guidelines approved algorithm.
Arm 2: Sentinel lymph node mapping according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy.
Secondary Objectives
To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy. A subset of study sites will also assess limb changes over time using lower extremity bioimpedance devices.
To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.
Exploratory Objectives
To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of
hysterectomy.
To explore the impact of patient characteristics (age, BMI, race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies.
To evaluate the cost-effectiveness of SLN mapping with or without completion of
lymphadenectomy for endometrial cancer.
Safety Objective
To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.