June 16 2025
The NRG-GY032 clinical trial is designed to test de-escalated adjuvant treatment in patients with POLE-mutated or p53 wild-type (wt) or no specific molecular profile (NSMP) early-stage endometrial cancer. This study is a collaborative effort between NRG Oncology and the Canadian Clinical Trials Group (CCTG).
“NRG-GY032 is determining whether we can tailor therapy for low-risk endometrial cancer patients after surgery and if that can help lower the risk of recurrence in patients treated with additional, de-escalated therapy based on their tumor molecular status,” stated Matthew Powell, MD, of the Division of Gynecologic Oncology at Washington University School of Medicine and Principal Investigator of the NRG-GY032 study.
Participants in NRG-GY032 will be enrolled in one of two potential sub-studies following surgery for their cancer,
RAINBO BLUE (Groups A1.1, A1.2, and A1.3) and
TAPER (Groups B1 and B2).
Patients who are eligible for “RAINBO BLUE” must havePOLE-mutated disease and will be observed after surgery. Our accrual goal is 120 patients.
The “TAPER” sub-study will include patients with p53wt or NSMP disease. Approximately 180 patients on the TAPER sub-study will either be observed or receive de-escalated adjuvant treatment.
The primary objective of this trial is to estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment based on their tumor molecular status. Additional objectives include estimating the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years as well as the recurrence-free, endometrial cancer-specific and overall survival.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website