PROfiling Based Endometrial Cancer Adjuvant Therapy

Last updated: March 26, 2025
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometrial Cancer

Treatment

Vaginal brachytherapy

Chemoradiation therapy

External beam radiotherapy

Clinical Study ID

NCT05179447
IRB-20210340-R
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Histologically confirmed endometrioid type endometrial carcinoma, InternationalFederation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of thefollowing 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

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 mixedtype), 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

Total Participants: 590
Treatment Group(s): 4
Primary Treatment: Vaginal brachytherapy
Phase:
Study Start date:
January 24, 2022
Estimated Completion Date:
January 01, 2027

Study 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.

Connect with a study center

  • Tongji Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

  • Women's Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Peking University Peoples Hospital

    Beijing,
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha,
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Hospital

    Guangzhou,
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo,
    China

    Active - Recruiting

  • Ningbo Women and Children's Hospital

    Ningbo,
    China

    Active - Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai,
    China

    Site Not Available

  • Shanghai First Maternity and Infant Hospital

    Shanghai,
    China

    Site Not Available

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