A Randomized Phase III Trial of Debulking Macroscopic Lymph Nodes vs. Concurrent Chemoradiotherapy (CCRT) for Stage ⅢCr (FIGO2018) of Cervical Cancer

Abstract

<h3>Purpose/Objective(s)</h3> In FIGO 2018, allowing assessment of retroperitoneal lymph nodes by imaging and/or pathological findings and, if deemed metastatic, the case is designated as stage IIIC (with r and p notations). External beam radiotherapy (EBRT) with concurrent chemotherapy followed by brachytherapy is still the standard treatment for stage IIICr of cervical cancer. Patients with lymph node metastases have lower overall survival (OS), progression free survival (PFS), and survival after recurrence, especially those who have unresectable macroscopically positive lymph nodes. Retrospective analysis suggests that there may be a benefit to debulk macroscopic nodes that would be otherwise difficult to sterilize with standard doses of radiation therapy. No prospective study reported that resecting macroscopic lymph nodes before CCRT would improve PFS or OS of cervical cancer. The CQGOG0103 study is a national, prospective, multicenter and randomized clinical study evaluating lymph node dissection on stage IIICr (FIGO2018) of cervical cancer. <h3>Materials/Methods</h3> Eligible patients are histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma. Stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm. 452 patients will be equally randomized to receive either CCRT (Pelvic EBRT/Extended-field EBRT + cisplatin (40mg/m2) or carboplatin (AUC=2) every week for 5 cycles + brachytherapy) or Open/minimally invasive pelvic and para-aortic lymph node dissection followed by CCRT. Randomization is stratified by status of para-aortic lymph node. The primary endpoint is PFS. Secondary endpoints are OS and surgical complications. The sample size calculation of 346 patients provides 80% power to detect a difference in survival at the two-sided 5% significance level using the log-rank test, considering a 20% reduction, a total of 452 patients are required. This study began in January 2021 and will be accrued within 4 years. Enrollment is ongoing. <h3>Results</h3> Enrollment is ongoing. <h3>Conclusion</h3> Enrollment is ongoing.