In short
Currently, there are 2 ongoing clinical trials investigating new approaches for treating and managing endometrial cancer stage I. These studies are exploring advanced imaging techniques for lymph node mapping and novel drug therapies aimed at early-stage disease. Trials are being conducted in the Netherlands, Italy, and Poland, offering opportunities for patients with high-risk or Grade 1 endometrial cancer to participate in cutting-edge research.
Clinical trial locations
- Italy
- Netherlands
- Poland
Study on Sentinel Lymph Node Mapping Using Gallium-68 Chloride and Tilmanocept in Patients with High-Risk Endometrial Cancer
This trial is focused on improving the way doctors identify whether cancer has spread to nearby lymph nodes in patients with high-risk stage I-II endometrial cancer. The study uses an advanced imaging technique called PET/CT scanning combined with a special substance called Gallium-68-tilmanocept.
Main goal: The primary aim is to determine whether this new imaging method can effectively locate sentinel lymph nodes—the first lymph nodes where cancer is likely to spread. By mapping these nodes accurately before surgery, doctors can better assess the extent of the disease and plan appropriate treatment.
Who can participate: Women aged 18 or older who have been diagnosed with stage I-II high or high-intermediate risk endometrial cancer are eligible. Participants must be scheduled for robot-assisted pelvic and para-aortic staging surgery and be able to provide informed consent.
Who cannot participate: Men, women with cancer stages other than I-II high or high-intermediate risk, and individuals considered part of vulnerable populations are excluded from this study.
What happens during the study: Participants receive an injection of Gallium-68-tilmanocept into the cervix, followed by a PET/CT scan to visualize the lymph nodes. The imaging results are then compared with findings from another method used during surgery. Researchers also examine the lymph nodes to check for cancer cells and monitor participants for any side effects up to one hour after the scan.
Investigational treatment: Gallium-68-tilmanocept is a radiopharmaceutical imaging agent that binds to immune cell receptors in lymph nodes, making them visible on PET/CT scans.
Study of Giredestrant for Patients with Grade 1 Endometrial Cancer
This study is testing a medication called giredestrant as a potential non-surgical treatment option for patients with early-stage, Grade 1 endometrial cancer. The trial is being conducted in Italy and Poland.
Main goal: The primary objective is to evaluate how effectively giredestrant can reduce or eliminate cancer after six months of treatment. Researchers will also monitor the safety and tolerability of the medication, assess how long the cancer regression lasts, and measure drug levels in the bloodstream.
Who can participate: Women with confirmed Grade 1 endometrial cancer of endometrioid type are eligible. They must have a performance status of 0 or 1, meaning they are fully active or have only minor symptoms. MRI scans must show that the tumor has not deeply invaded the uterine muscle (less than 50% invasion) and that there is no cancer outside the uterus. Participants must be willing to take the medication for at least six continuous cycles before considering surgery.
Who cannot participate: Women with cancer types other than Grade 1 endometrial cancer, those who are pregnant or breastfeeding, patients with serious health conditions that could interfere with the study, and those unable to provide informed consent are excluded. Individuals with allergies to the study medication or who have recently participated in another clinical trial may also be ineligible.
What happens during the study: Participants take giredestrant orally in capsule form for a minimum of six continuous cycles. Regular assessments are conducted throughout treatment to monitor cancer regression and any side effects. At the six-month mark, detailed evaluations determine whether the cancer has decreased or disappeared. If necessary, surgery may be performed after this assessment period.
Investigational treatment: Giredestrant is a selective estrogen receptor degrader that works by targeting and modulating estrogen receptors, which can inhibit cancer cell growth in hormone receptor-positive cancers.
Summary
The two ongoing clinical trials for stage I endometrial cancer represent distinct approaches to improving patient care. The Netherlands-based study focuses on advanced imaging technology to better detect cancer spread before surgery, while the Italy and Poland trial explores a potential medication-based alternative to immediate surgery for early-stage disease. Both studies target specific patient populations—high-risk stage I-II patients in the imaging study and Grade 1 patients in the drug trial. These complementary research efforts reflect the growing understanding that endometrial cancer at stage I may benefit from personalized approaches based on risk factors and disease characteristics. Patients interested in participating should discuss eligibility with their healthcare providers to determine which trial, if any, might be appropriate for their specific situation.
