NCT Number: NCT05179447
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.
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Not applicable
Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II
Exclusion criteria
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy.
For brachytherapy administered after completion of External beam radiotherapy (EBRT):
Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Time frame: 3 years
Vaginal, pelvic or distant recurrence as first failure
Time frame: 3 years, 5 years
Relapse-free survival (survival without relapse)
Time frame: 3 years, 5 years
Overall survival (all-cause death)
Time frame: 3 years, 5 years
Treatment-related symptoms according to CTCAE v 5.0
Time frame: 3 years, 5 years
Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on Quality of Life Core Questionnaire-30 functioning scales, general quality of life and general cancer symptoms, quite a bit/very much vs no or mild symptoms
Time frame: 3 years, 5 years
All hospital based health care costs used with primary treatment or during followup for treatment of adverse events and/or treatment for relapse
Time frame: 3 years, 5 years
Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms
Contact information is provided by the study sponsor or research team.
Xinyu Wang, MD
CONTACT
Yang Li, PhD
CONTACT
Women's Hospital School Of Medicine Zhejiang University
Other
Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
Acronym: PROBEAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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