PROfiling Based Endometrial Cancer Adjuvant Therapy

Not Applicable

Recruiting

• Conditions: Endometrial Cancer Stage II; Endometrial Cancer Stage I

• Registration Number: NCT05179447
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Study Start: 2022-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 590

Inclusion Criteria

1. Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection, with or without para-aortic lymphadenectomy, oophorectomy

2. Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage and grade:

   Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II

3. World Health Organization (WHO)-performance status 0-2

4. Written informed consent

Exclusion Criteria

1. With residual disease
2. Any other stage and type of endometrial carcinoma
3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
4. Uterine sarcoma (including carcinosarcoma)
5. Previous malignancy (except for non-melanomatous skin cancer)
6. Previous pelvic radiotherapy
7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total recurrence	3 years	Vaginal, pelvic or distant recurrence as first failure

Secondary Outcome Measures

Name	Time	Method
Adverse events	3 years, 5 years	Treatment-related symptoms according to CTCAE v 5.0
Health-related cancer-specific quality of life	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
Survival	3 years, 5 years	Overall survival (all-cause death)
Relapse-free survival	3 years, 5 years	Relapse-free survival (survival without relapse)
Endometrial cancer related health care costs	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

Trial Locations

Locations (10)

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