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PROfiling Based Endometrial Cancer Adjuvant Therapy
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Summary
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.
Official title: Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
590
Start Date
2022-01-24
Completion Date
2027-01-01
Last Updated
2025-04-01
Healthy Volunteers
No
Interventions
Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy. For brachytherapy administered after completion of External beam radiotherapy (EBRT): Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
External beam radiotherapy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
Observation
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
Chemoradiation therapy
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Locations (10)
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Peking University Peoples Hospital
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
Sun Yat-Sen University Cancer Hospital
Guangzhou, China
Ningbo First Hospital
Ningbo, China
Ningbo Women and Children's Hospital
Ningbo, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Shanghai First Maternity and Infant Hospital
Shanghai, China