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PROfiling Based Endometrial Cancer Adjuvant Therapy

RecruitingNAAges 18 Years - 75 YearsFemaleWomen's Hospital School Of Medicine Zhejiang Univ…
NCT05179447 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Vaginal brachytherapy
  • External beam radiotherapy
  • Observation
  • Chemoradiation therapy
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Where

10 sites
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, China
Qilu Hospital of Shandong University
Jinan, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, 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

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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