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PROfiling Based Endometrial Cancer Adjuvant Therapy — PROBEAT  

Endometrial Cancer Stage I Clinical Trial

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

Clinical Trial Summary

This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.

Clinical Trial Description

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, Lymph-Vascular Space Invasion (LVSI) and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) have become available which are strongly related to outcomes and risk of cancer spread. Based on 2022 National Comprehensive Cancer Network (NCCN) guideline and the ongoing "Portec-4a" trial, this randomized trial using integrated genomic-pathologic classification to assign adjuvant treatment for women with stage I-II high-intermediate and intermediate risk endometrioid adenocarcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05179447
Study type Interventional
Source Women's Hospital School Of Medicine Zhejiang University
Contact Xinyu Wang, MD
Phone +86-571-87061501
Email wangxinyu@zju.edu.cn
Status Recruiting
Phase N/A
Start date January 24, 2022
Completion date January 1, 2027
View Details
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