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

doi:10.3760/cma.j.issn.1004-4221.2018.08.009

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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).

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	Articles by authors
	Li Dan
	Wen En
	Lin Shen
	Zhang Yingjie
	He Lijia
	Ren Peirong
	Shang Changling
	Xiang Li
	Yang Hongru
	Zhang Jianwen
	Fan Juan
	Wen Qinglian
	Wu Jingbo

Key words： Uterine cervical neoplasm/brachytherapy Clinical trial

Received: 09 October 2017

Corresponding Authors: Wu Jingbo,Email:wjb6147@163.com

Cite this article:

Li Dan,Wen En,Lin Shen et al. 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[J]. Chinese Journal of Radiation Oncology, 2018, 27(8): 753-758.

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http://journal12.magtechjournal.com/Jweb_fszlx/EN/10.3760/cma.j.issn.1004-4221.2018.08.009 OR http://journal12.magtechjournal.com/Jweb_fszlx/EN/Y2018/V27/I8/753

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