NCT05179447

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, Lymph-Vascular Space Invasion (LVSI) and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) have become available which are strongly related to outcomes and risk of cancer spread. Based on 2022 National Comprehensive Cancer Network (NCCN) guideline and the ongoing "Portec-4a" trial, this randomized trial using integrated genomic-pathologic classification to assign adjuvant treatment for women with stage I-II high-intermediate and intermediate risk endometrioid adenocarcinoma.

Conditions

• Endometrial Cancer Stage I
• Endometrial Cancer Stage II

Interventions

Type	Name	Description
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 )

Timeline

• Start date: 2022-01-24
• Primary completion: 2026-12-31
• Completion: 2027-01-01
• First posted: 2022-01-05
• Last updated: 2025-04-01

Locations

10 sites across 1 country: China