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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
590
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 )
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGWomen's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPeking University Peoples Hospital
Beijing, China
NOT_YET_RECRUITINGXiangya Hospital of Central South University
Changsha, China
RECRUITINGSun Yat-Sen University Cancer Hospital
Guangzhou, China
NOT_YET_RECRUITINGNingbo First Hospital
Ningbo, China
RECRUITINGNingbo Women and Children's Hospital
Ningbo, China
RECRUITINGObstetrics & Gynecology Hospital of Fudan University
Shanghai, China
NOT_YET_RECRUITINGShanghai First Maternity and Infant Hospital
Shanghai, China
NOT_YET_RECRUITINGTotal recurrence
Vaginal, pelvic or distant recurrence as first failure
Time frame: 3 years
Relapse-free survival
Relapse-free survival (survival without relapse)
Time frame: 3 years, 5 years
Survival
Overall survival (all-cause death)
Time frame: 3 years, 5 years
Adverse events
Treatment-related symptoms according to CTCAE v 5.0
Time frame: 3 years, 5 years
Health-related cancer-specific quality of life
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
Endometrial cancer related health care costs
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
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