PROfiling Based Endometrial Cancer Adjuvant Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWomen's Hospital School Of Medicine Zhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
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
World Health Organization (WHO)-performance status 0-2
Written informed consent
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Vaginal brachytherapy
- External beam radiotherapy
- Observation
- Chemoradiation therapy
Treatment groups
590 Participants
are divided into 2 treatment groupsLocations
10Tongji Hospital, Huazhong University of Science and Technology WuhanHubei, China
Qilu Hospital of Shandong University JinanShandong, China
Women's Hospital School of Medicine Zhejiang University310000, HangzhouZhejiang, China
Peking University Peoples Hospital Beijing China
Sponsors and collaborators
Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Tongji Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Sun Yat-sen University
Collaborator
Peking University People's Hospital
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Ningbo No. 1 Hospital
Collaborator
Source ClinicalTrials.gov