October 12 2022
NRG-CC010: A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer
Endometrial cancer is currently the most common gynecologic malignancy diagnosed in women [Siegel, 2021]. Most patients who present with endometrial cancer are diagnosed at an early-stage of the disease and undergo a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy to eradicate their cancer. However, data from the NRG-GOG 0033 trial indicates that some risk factors correlate strongly with lymphatic spread including grade, depth of myometrial invasion, and lymphovascular space invasion [Creasman, 1987]. Complications arise with trying to identify which patients are at higher risk of lymphatic metastasis.
Sentinel lymph node (SLN) mapping has been proposed as an alternative to complete lymphadenctomy in patients with early-stage endometrial cancer due to evidence that it may improve survival outcomes for patients, but there is no clear evidence that SLN mapping reduces risk of lower extremity lymphedema in endometrial cancer patients when compared to lymphadenectomy. NRG-CC010 was designed to address whether the use of SLN mapping can improve quality of life for patients by reducing the incidence of post-operative lower extremity limb dysfunction in patients.
“CC010 will provide a definitive answer about the potential ability of sentinel lymph node mapping to reduce lymphedema risk in women with endometrial cancer. Given the increasing rate of endometrial cancer in the United States, this trial will greatly benefit our patients,” stated Edward J. Tanner, III, MD, Chief of Gynecologic Oncology service at Northwestern University, Director of Gynecologic Robotic Surgery at Prentice Women’s Hospital, and Principal Investigator of the NRG-CC010 trial.
Patients enrolled in NRG-CC010 will be randomized to one of two study arms following their enrollment and preoperative assessment as well as their surgical intervention. If SLN is not identified on both sides of the pelvis for patients in Study Arm 1, the patient will undergo a side-specific pelvic lymphadenectomy on any side that does not map according to GOG staging criteria [Gynecologic Oncology Group, 2012]. Additionally, a side-specific para-aortic lymphadenectomy, to the level of the inferior mesenteric artery, should be attempted in patients in Study Arm 1 with failed mapping if para-aortic lymphadenectomy was declared by the surgeon prior to revealing Arm assignment.
Patients in Study Arm 2 will undergo a complete pelvic lymphadenectomy following SLN mapping according to GOG staging criteria. Patients in Study Arm 2 will also undergo bilateral para-aortic lymphadenectomy to the level of the inferior mesenteric artery if declared by the surgeon prior to revealing Arm assignment.
Omentectomy or omental biopsy should be performed for patients with high grade histologies in either Study Arm.
Secondary and exploratory objectives of the NRG-CC010 trial also include comparing changes in lower extremity limb circumference in patients, limb changes over time using lower extremity bioimpedance devices, validating 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, comparing adjuvant therapy decisions in patients, exploring the impact of patient characteristics, extent of lymph node dissection, and adjuvant therapy decisions, on the development of lower extremity limb dysfunction and their interaction with lymph nod assessment strategies, and evaluating the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy.
This clinical trial is currently active and accruing patients.
Protocol documents and materials are located on the CTSU website
Citations
Creasman, W., et al., Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer, 1987. 60(8): p. 2035-41.
Gynecologic Oncology Group., authors Surgical Procedures Manual. Buffalo, NY: Gynecologic Oncology Group; 2007. [Accessed February 18, 2021]. http://www.gog.org
Siegel, R.L. et al, Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33.