PROfiling Based Endometrial Cancer Adjuvant Therapy (PROBEAT)
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- STATUS
- Recruiting
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- End date
- Jan 1, 2026
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- participants needed
- 590
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- sponsor
- Women's Hospital School Of Medicine Zhejiang University
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.
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.
Details
| Condition | Endometrial Cancer Stage I, Endometrial Cancer Stage II |
|---|---|
| Treatment | Observation, External Beam Radiotherapy, Vaginal Brachytherapy, Chemoradiation therapy, Chemoradiation therapy |
| Clinical Study Identifier | NCT05179447 |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University |
| Last Modified on | 10 May 2022 |
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