Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma

What this Trial Is About

Researchers are investigating the use of integrated genomic-pathologic classification to guide adjuvant therapy decisions for women with early-stage endometrioid adenocarcinoma of the endometrium who have high-intermediate and intermediate risk features. This phase III randomized trial compares molecular profile-based treatment strategies with standard radiation therapy to better tailor treatment and potentially prevent overtreatment. The study builds on established risk factors and incorporates molecular-genetic information to refine patient care. Participants are assigned to different treatment groups based on their molecular and pathological profiles. One group receives no adjuvant therapy if they have a POLE-mutated profile, vaginal brachytherapy for an intermediate profile, or chemo-radiotherapy for a p53-abnormal profile. The comparator group receives standard treatment consisting of vaginal brachytherapy for intermediate risk cases and external beam pelvic radiotherapy for high-intermediate risk cases. The study treatments involve radiation methods such as vaginal brachytherapy, external beam radiotherapy, and chemotherapy combined with radiation. During the study, women undergo active follow-up including quality of life questionnaires and monitoring for cancer recurrence or progression over 3 to 5 years. Assessments include relapse-free survival, overall survival, adverse events, cancer-specific quality of life, and healthcare costs related to endometrial cancer. The primary outcome focuses on total cancer recurrence within three years. This comprehensive monitoring aims to evaluate the impact of personalized adjuvant therapy on patient outcomes over the study period.

PROfiling Based Endometrial Cancer Adjuvant Therapy