NCT05179447Recruiting
PROfiling Based Endometrial Cancer Adjuvant Therapy
Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 590 (estimated)
- First submitted
- 16 Dec 2021
- Start date
- 24 Jan 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Diseases
- Endometrial cancer
- NCT number
- NCT05179447
What you commit to
- Study type: Interventional
- Planned participants: 590
- From 24 Jan 2022 to the primary completion date, 31 Dec 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Expected interval between the operation and start of radiotherapy exceeding 8 weeks
Other illness
- With residual disease
- Previous malignancy (except for non-melanomatous skin cancer)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sun Yat-sen University Cancer Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Women's hospital school of medicine Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Ningbo Women and Children's Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Obstetrics&Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai First Maternity and Infant Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Tongji Hospital, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.