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
10.3760/cma.j.issn.1004-4221.2018.08.009
- VernacularTitle: 单管式子宫颈癌后装施源器前瞻性随机对照Ⅱ期临床研究近期疗效
- Author:
Dan LI
1
;
En WEN
;
Shen LIN
;
Yingjie ZHANG
;
Lijia HE
;
Peirong REN
;
Changling SHANG
;
Li XIANG
;
Hongru YANG
;
Jianwen ZHANG
;
Juan FAN
;
Qinglian WEN
;
Jingbo WU
Author Information
1. Department of Oncology, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China (Current Affiliation of Wen En: Department of Oncology, First People′s Hospital of Neijiang)
- Publication Type:Journal Article
- Keywords:
Uterine cervical neoplasm/brachytherapy;
Clinical trial
- From:
Chinese Journal of Radiation Oncology
2018;27(8):753-758
- CountryChina
- Language:Chinese
-
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).
