Abstract
BackgroundCurrently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a thrice-weekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety, and efficacy of NACT with weekly TP followed by CCRT.MethodsThis is a prospective, randomized, open-labeled, multicentered phase III study. Based on a 65% of 2-year disease-free survival (DFS) rate in the CCRT group and 80% of that in NACT followed by CCRT group, and on prerequisite conditions including an 8% loss to follow-up, a two-sided 5% of type I error probability, and an 80% of power, a total of 300 cases were required for enrollment. Patients with IIB–IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. In the study arm, patients will receive dose-dense cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m2 weekly) plus image-guided adaptive brachytherapy (IGBRT). In the control arm, patients will undergo CCRT treatment. The primary endpoint of the study is 2-year disease-free survival (DFS); the secondary endpoints are 5-year overall survival (OS) and disease-free survival (DFS), the response rate 3 months after treatment completion, grade III/IV adverse effects, and quality of life, and potential biomarkers for predicting treatment response will also be studied.DiscussionThe data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer.Trial registrationChinese Clinical Trial Registry ChiCTR1900025327. Registered on 24 August 2019. medresman.org.cn ChiCTR1900025326
Highlights
The standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT)
The data gathered from the study will be used to determine whether neoadjuvant chemotherapy (NACT) with weekly The cisplatin/paclitaxel (TP) followed by CCRT may become an optimized treatment for locally advanced cervical cancer
This study aims to investigate the feasibility, safety, and efficacy of NACT with weekly TP followed by CCRT
Summary
The standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. The standard treatment for locally advanced cervical cancer (LACC) is currently concurrent chemoradiation (CCRT). The response rate, the clinical and pathological responses to NACT, ranged from 58.49 to 86.54% and 7.5 to 78.81%, respectively; the treatment response indicated that LACC was sensitive to chemotherapy. Para-aortic (PA) spread in cervical cancer is associated with a poor prognosis, despite the use of optimal first-line treatment, including chemoradiation therapy with extended field radiotherapy (EFR). Studies [5, 6] have suggested that adjuvant chemotherapy leads to better outcomes than chemoradiation therapy alone especially in PA-spread cervical cancer patients, despite increased toxicity
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