Personalized treatment for endometrial cancer based on genetic profiling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates how integrated genomic-pathologic classification can guide adjuvant therapy decisions for women with high-intermediate and intermediate risk endometrioid adenocarcinoma. Participants will be randomized to receive either no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy, or chemoradiation therapy based on their molecular features, compared to standard radiation therapy. The goal is to tailor treatment to reduce the risk of cancer relapse while avoiding overtreatment. This multicenter approach involves several prominent hospitals in China.

Why it matters

Who can join: the full rules

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

Where it's running

• Tongji Hospital, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting
• Women's Hospital School of Medicine Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, China Recruiting
• Ningbo First Hospital
  Ningbo, China Recruiting
• Ningbo Women and Children's Hospital
  Ningbo, China Recruiting

Study contacts

• Principal investigator: Xinyu Wang, MD — Women's Hospital School Of Medicine Zhejiang University
• Study coordinator: Xinyu Wang, MD
• Email: wangxinyu@zju.edu.cn
• Phone: +86-571-87061501

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating Sentinel Node Biopsy for Endometrial Cancer Treatment

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.