Extended field or pelvic intensity-modulated radiotherapy with concurrent cisplatin chemotherapy for the treatment of post-surgery multiple pelvic lymph node metastases in cervical cancer patients: a randomized, multi-center phase II clinical trial.

Abstract

BackgroundTo prospectively compare the outcomes and side effects between groups of postoperative cervical cancer patients with multiple pelvic lymph node metastases who were treated with extended field or pelvic intensity-modulated radiotherapy (IMRT) with concurrent cisplatin chemotherapy.MethodsCervical carcinoma patients with International Federation of Gynecology and Obstetrics (FIGO) stage Ib-IIa, who underwent radical hysterectomy and had histologically confirmed multiple (≥2) pelvic lymph node metastases, were enrolled into this study. The patients were randomly assigned to pelvic-IMRT or extended field-IMRT (45 Gy/25 Fx) group. Patients in either group received concurrent cisplatin chemotherapy (40 mg/m2) starting on the first day of irradiation.ResultsUntil December 31th 2017, 129 patients were initially enrolled into this study. During the study, 3 patients were dropped out due to either incompletion of the study or exclusion by the criteria. Consequently, 64 patients completed pelvic-IMRT, and 62 patients completed extended field-IMRT. Median follow-up period was 61.30 months in the extended field-IMRT group and 60.60 months in the pelvic-IMRT group. Five-year actuarial survival probability was 0.759 (95% CI: 0.619–0.854) in the extended field-IMRT group which was not significantly different from that of the pelvic-IMRT group [0.824 (95% CI: 0.690–0.905), P=0.442]. Similarly, the five-year progression-free probability was 0.720 (95% CI: 0.576–0.822) in the extended field-IMRT group, which was not significantly different from that of the pelvic-IMRT group [0.781 (95% CI: 0.637–0.874), P=0.389]. In addition, there was no significant difference between the two groups in hematology and gastrointestinal tract toxicities.ConclusionsPost-operative pelvic-IMRT or extended field-IMRT with concurrent cisplatin chemotherapy had similar outcomes in terms of survival rates and adverse events in cervical carcinoma patients at FIGO stage Ib-IIa with multiple pelvic lymph nodes metastases.