OBJECTIVE: To evaluate the efficacy and safety of extended-field intensity-modulated radiotherapy (EF-IMRT) combined with concurrent chemotherapy and high-dose-rate (HDR) brachytherapy in locally advanced cervical cancer with positive para-aortic (PALN) or common iliac lymph nodes (CILN). METHODS: A multicenter prospective study was conducted involving patients diagnosed with biopsy-proven cervical cancer and positive PALN or CILN, enrolled from 11 hospitals in China. All patients were treated with EF-IMRT with concurrent chemotherapy followed by HDR brachytherapy. The primary endpoint was progression-free survival (PFS), with overall survival (OS), local progression-free survival (LPFS), distant metastasis-free survival (DMFS), and adverse events as secondary endpoints. RESULTS: Between October 2015 and July 2018, 204 patients with cervical cancer were evaluable in this study, with a median follow-up of 68.7 months. The 3-year and 5-year PFS were 68.3% and 64.6%, respectively. OS at 3 and 5 years were 76.4% and 69.5%, respectively. The 5-year LPFS and DMFS were 83.1% and 70.1%, respectively. Notably, patients with positive PALN had significantly lower PFS, OS, LPFS, and DMFS compared to those with negative PALN (p<0.05). Among patients with PALN involvement, those with positive CILN exhibited significantly lower PFS and DMFS compared to those with negative CILN (p<0.05). Acute grade ≥3 gastrointestinal toxicities occurred in 16.7% of patients, and chronic grade ≥3 gastrointestinal toxicities were observed in 3% of patients. CONCLUSION: This multicenter study demonstrated that EF-IMRT with concurrent chemotherapy was tolerable and effective for cervical cancer, with favorable local control and OS outcomes. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR) Identifier: 17011347.
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