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 groupsSponsors 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