Background: Gastric-type endocervical adenocarcinoma (G-EAC) is a distinctive form of adenocarcinoma that is not associated with human papillomavirus.This neoplasm exhibits a low incidence, low screening and biopsy positivity, low preoperative diagnosis, and a high susceptibility to underdiagnosis and misdiagnosis.It is associated with a poor prognosis for patients.Currently, there is an absence of a standardized postoperative adjuvant treatment plan for G-EAC, which constitutes an urgent clinical problem that demands resolution.However, there is still no prospective analysis on the adjuvant treatment of cervicogastric adenocarcinoma.This study is the first randomized phase III trial, which aims to recommend better adjuvant treatment options for G-EAC patients at high risk of recurrence in China, in order to better optimize and personalize patient care and improve progression-free survival (PFS) and overall survival (OS).Methods: This trial is a prospective, multicenter study led by the Department of Radiotherapy, Women's Hospital of Zhejiang University.Recruitment will begin in March 2025, and it is expected that 238 patients with postoperative G-EAC with high risk of recurrence will be recruited from 16 clinical centers in China.Patients will be randomly assigned to the experimental group or the control group in a 1:1 ratio.The experimental group will receive paclitaxel combined with platinum-based concurrent chemoradiotherapy (CCRT) and short-term adjuvant chemotherapy, and the control group will receive the current standard treatment regimen, i.e., platinum-based CCRT, without adjuvant chemotherapy.The primary endpoint of the study is the 2-year PFS rate, and the secondary endpoints are disease treatment failure pattern, OS rate, acute/chronic toxicity incidence, and quality of life assessment.
Qu et al. (Thu,) studied this question.