A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer
NRG Oncology
Summary
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
Description
PRIMARY OBJECTIVES: I. To compare the rates of lower extremity limb dysfunction (defined as a \>= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire \[GCLQ\] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy: Ia. Sentinel lymph node mapping and excision followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration * Clinical stage I endometrial cancer based on the following diagnostic workup: * History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 * Patients with a…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureDiagnostic Imaging Testing
Undergo imaging
- ProcedureExcisional Biopsy
Undergo sentinel lymph node excision
- DrugIndocyanine Green Solution
Given via injection
- ProcedureMinimally Invasive Surgery
Undergo minimally invasive hysterectomy
- ProcedurePelvic Lymphadenectomy
Undergo pelvic lymphadenectomy
- OtherQuestionnaire Administration
Locations (55)
- George Washington University Medical CenterWashington D.C., District of Columbia
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at DoralDoral, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida
- UM Sylvester Comprehensive Cancer Center at KendallMiami, Florida