PROfiling Based Endometrial Cancer Adjuvant Therapy (PROBEAT)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    590
  • sponsor
    Women's Hospital School Of Medicine Zhejiang University
Updated on 10 May 2022

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 IdentifierNCT05179447
SponsorWomen's Hospital School Of Medicine Zhejiang University
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
World Health Organization (WHO)-performance status 0-2
Written informed consent

Exclusion Criteria

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

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