Evaluation of clinical efficacy and safety of single-channel intracavitary applicator for uterine cervical cancer: early results of a prospective randomized phase Ⅱ clinical trial / 中华放射肿瘤学杂志

ABSTRACT

Objective@#To evaluate whether the self-designed single-channel intracavitary applicator yields equivalent clinical efficacy and safety to the standard Fletcher-type three-channel applicator in the high-dose-rate (HDR) brachytherapy for uterine cervical cancer.@*Methods@#From December 2011 to April 2017, patients initially diagnosed with cervical cancer were randomly assigned into the external beam radiotherapy (EBRT)+ single-channel intracavitary applicator group (the patent single-channel group) and EBRT+ the Fletcher applicator group. Whole pelvis irradiation was delivered with 6-MV photons via a four-field box variant or anterior and posterior parallel fields. Five to six fractions of intracavitary brachytherapy were performed at a dose of 7 Gy at point A once a week after 30 Gy (BED at point A 80-90 Gy). Chemotherapy was given with intravenous injection of cisplatin at a dose of 40 mg/m2 once weekly during EBRT.Clinical efficacy and safety were evaluated after the treatment.@*Results@#In total, 150 eligible cases were assigned into the Fletcher applicator group and 149 cases into the patent single-channel group. The short-term clinical efficacy and acute toxicity did not significantly differ between two groups. The response rate was 94.0% in the Fletcher group, and 94.7% in the patent single-channel group. In the Fletcher applicator group, 76(50.7%) patients developed ≥ grade 3 hematologic toxicity and 61(40.9%) in the patent group (P=0.195).@*Conclusions@#The self-designed patent single-channel intracavitary applicator yields equivalent clinical efficacy and safety (acute toxicity) to the standard Fletcher-type three-channel applicator in the HDR brachytherapy for uterine cervical cancer.@*Clincal Trial Registration@#Chinese Clinical Trial Registry (ChiCTR-TRC-12002321).