February 12 2024
NRGOncology recently sat down with NRG-CC010 study co-Principal Investigator (PI),Dr. Edward Tanner, to discuss the phase III trial of assessing the impact ofsentinel lymph node (SLN) mapping on patient-reported lower extremity limbdysfunction in patients with endometrial cancer. Watch the video interview orread the written interview below
Interview with Edward Tanner, MD, Chief of Gynecologic Oncology at Northwestern Medicine and Co-Principal Investigator of NRG-CC010.
Q: Can you provide an overview of the study?
A: NRG-CC010 is a randomized trial evaluating two lymphatic assessment strategies for patients undergoing surgery for endometrial cancer. Our objective is to determine whether sentinel lymph node mapping can reduce the incidence of lower extremity limb dysfunction in patients undergoing surgery for endometrial cancer. Traditionally, we would remove or sample all of the lymph nodes in the pelvis in patients undergoing staging for endometrial cancer. This can lead to chronic lower extremity limb edema called lymphedema. Sentinel lymph node mapping allows us to target specific lymph nodes in the pelvis and remove just one or two lymph nodes on either side of the pelvis. Our hypothesis is that sentinel lymph node mapping will reduce the risk of lower extremity limb dysfunction in these patients.
Q: What are the aims of this study?
A: NRG-CC010 is a unique study in that it’s a surgical trial powered with a patient-centered outcome which is evaluating lower extremity limb dysfunction using patient questionnaires, the gynecologic question lymphedema questionnaire, and tracking that over time. We also have a number of really exciting secondary and exploratory endpoints attached to the trial as well. Our goal is to try to identify whether there are any early predictors of lymphedema before patients develop symptoms. Our hope is, by identifying these markers, we may be able to develop future interventional trials to identify lymphedema early and then build in interventions that can reduce the development of lymphedema over time.
Q: What are the most common questions you receive about this study?
A: The most common questions that we get at this point relate to how lymphatic assessment occurs in the operating room. That’s because there is an NCCN algorithm for sentinel lymph node mapping and it’s really important that surgeons understand exactly how to remove lymph nodes and what to do if the mapping doesn’t work on one side of the pelvis depending whether they are on the study arm or the control arm. Certainly, we are happy to speak to potential investigators about how their current practice can fit into that and to make sure they understand exactly how sentinel lymph node mapping fits into the protocol.
Q: Is there anything else researchers should know about this study?
A: In this trial, our goal is to ensure that we do have good representation of underrepresented minorities. The study is run through the NCORP, so we are trying to enroll patients through underrepresented minority sites within NCORP. That is a core part of the study because we know that patients with endometrial cancer in these groups are not well represented in clinical trials. Our goal is to make sure that patients are well cared for and that we are improving quality of life for all patients with gynecologic cancers.