Personalized treatment for endometrial cancer based on genetic profiling
Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
This study is testing if using genetic information can help doctors choose the best follow-up treatment for women with certain types of endometrial cancer to lower the chance of the cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | radiation |
| Locations | 10 sites (Wuhan, Hubei and 9 other locations) |
| Trial ID | NCT05179447 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with stage I or II endometrioid adenocarcinoma who meet specific histological and performance status criteria.
Not a fit: Patients with residual disease, other types of endometrial carcinoma, or those who have received previous pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for women with endometrial cancer, potentially improving outcomes and reducing unnecessary side effects.
How similar studies have performed: Other studies have shown promise in using genomic profiling to tailor cancer treatments, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhan, Hubei and 9 other locations
- 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)
- Peking University Peoples Hospital — Beijing, China (Not_yet_recruiting)
- Xiangya Hospital of Central South University — Changsha, China (Recruiting)
- Sun Yat-Sen University Cancer Hospital — Guangzhou, China (Not_yet_recruiting)
- Ningbo First Hospital — Ningbo, China (Recruiting)
- Ningbo Women and Children's Hospital — Ningbo, China (Recruiting)
- Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (Not_yet_recruiting)
- Shanghai First Maternity and Infant Hospital — Shanghai, China (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.