Nodal Sampling for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two methods for checking lymph nodes during surgery for endometrial cancer, which affects the uterine lining. The goal is to determine which method helps patients remain cancer-free longer after surgery. One group will undergo a selective surgical staging procedure, while the other will have a sentinel node procedure. Women who may qualify have endometrial cancer confined to the uterus and are scheduled for a specific type of surgery.
As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on chemotherapy, hormone therapy, or immunotherapy for your endometrial cancer, you cannot participate in the trial.
What prior data suggests that these surgical staging methods are safe for endometrial cancer patients?
Research has shown that selective surgical staging for endometrial cancer is generally well-tolerated. Studies comparing surgical outcomes indicate a low risk of serious complications. For instance, one study found that in early-stage endometrial cancer, positive outcomes were common, with negative events occurring in only about 1.56% of cases, indicating that serious adverse events are rare.
Moreover, another study discovered that survival rates, both disease-free and overall, are similar when comparing selective surgical staging with other methods. This supports the idea that the safety of selective surgical staging is comparable to other approaches.
Overall, these findings suggest that selective surgical staging is a safe option for patients with endometrial cancer, with very few reports of serious side effects.12345Why are researchers excited about this trial?
Researchers are excited about the nodal sampling method for endometrial cancer because it aims to improve surgical precision and potentially reduce unnecessary procedures. Unlike traditional methods that might involve removing numerous lymph nodes, this approach uses selective surgical staging with side-specific lymphadenectomy, allowing for a more targeted removal based on intraoperative consultation between the pathologist and surgeon. This could lead to fewer complications and quicker recovery times for patients. Additionally, the incorporation of a sentinel node procedure as a comparator might provide further insights into the most effective way to stage and treat endometrial cancer.
What evidence suggests that this trial's treatments could be effective for endometrial cancer?
This trial will compare two approaches for nodal sampling in endometrial cancer: Selective Surgical Staging with side-specific lymphadenectomy (LAD) and the REFLEX side-specific LAD. Research has shown that carefully selecting surgeries can benefit some women with endometrial cancer. One study found that removing both pelvic and para-aortic lymph nodes increased 5-year survival rates by 10.6%. This suggests that checking and removing certain lymph nodes might help control cancer spread. However, other research indicates no significant difference in overall survival when comparing a smaller lymph node test, called a sentinel lymph node biopsy, to removing all lymph nodes. The trial aims to find the best method for checking lymph nodes during surgery while weighing the risks and benefits.24678
Who Is on the Research Team?
Rachel Miller, M.D.
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for women with endometrial cancer confined to the uterus, who can undergo surgery and have a life expectancy of at least 6 months. They should understand the study and consent to participate. Prior chemotherapy is okay if it was over five years ago with no current disease. Women must not be pregnant, have had prior pelvic lymphadenectomy or irradiation, or severe allergies to iodine/ICG.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Staging
Participants undergo selective surgical staging or sentinel node procedure for lymph node evaluation
Follow-up
Participants are monitored for recurrence-free survival, progression-free survival, and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- REFLEX
- Selective surgical staging
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rachel Miller
Lead Sponsor