Phase III Study Comparing One-Year Olaparib Maintenance Therapy versus Observation After Chemoradiation in Women with p53abn Endometrial Cancer

What this Trial Is About

Researchers are investigating personalized treatments for patients with endometrial cancer based on their molecular profiles. This study, part of the RAINBO program, focuses on patients with p53 abnormal endometrial cancer who have completed standard adjuvant chemoradiation therapy. The goal is to see if maintenance treatment with the drug Olaparib can improve recurrence-free survival compared to observation alone. Participants are randomly assigned to either receive Olaparib at a dose of 300 mg twice daily for one year or to be closely observed without additional treatment. All patients have undergone surgery and sequential radiotherapy and chemotherapy, typically following the PORTEC-3 regimen or similar local protocols. The study monitors patients over a three-year period to assess the primary outcome of recurrence-free survival. During the study, participants will have regular assessments including tumor evaluations, organ function tests, and overall health monitoring to ensure safety and treatment adherence. Researchers will also collect data on side effects and disease status throughout the treatment and follow-up periods. The total participation time extends up to three years, including the one-year treatment or observation phase and subsequent monitoring.

Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer