Spots Global Cancer Trial Database for PROfiling Based Endometrial Cancer Adjuvant Therapy
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Trial Identification
Brief Title: PROfiling Based Endometrial Cancer Adjuvant Therapy
Official Title: Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
Study ID: NCT05179447
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China
Peking University Peoples Hospital, Beijing, , China
Xiangya Hospital of Central South University, Changsha, , China
Sun Yat-Sen University Cancer Hospital, Guangzhou, , China
Ningbo First Hospital, Ningbo, , China
Ningbo Women and Children's Hospital, Ningbo, , China
Obstetrics & Gynecology Hospital of Fudan University, Shanghai, , China
Shanghai First Maternity and Infant Hospital, Shanghai, , China
Contact Details
Name: Xinyu Wang, MD
Affiliation: Women's Hospital School Of Medicine Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
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