PROfiling Based Endometrial Cancer Adjuvant Therapy

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.

Conditions

• Endometrial Cancer Stage I
• Endometrial Cancer Stage II

Interventions

RADIATION

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

RADIATION

External beam radiotherapy

External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions

OTHER

Observation

No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment

COMBINATION_PRODUCT

Chemoradiation therapy

4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )

Sponsors & Collaborators

• Tongji Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Anhui Provincial Cancer Hospital

  collaborator OTHER

• Ningbo Women & Children's Hospital

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  lead OTHER

Principal Investigators

• Xinyu Wang, MD · Women's Hospital School Of Medicine Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-24

Primary Completion

2026-12-31

Completion

2027-01-01

Countries

• China

Study Locations