title: A phase I study of adjuvant intensity-modulated radiotherapy with concurrent paclitaxel and cisplatin for cervical cancer patients with high risk factors.
abstract: The aim of the study is to determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLTs) of adjuvant concurrent paclitaxel and cisplatin (TP) with pelvic intensity-modulated radiotherapy (IMRT) for early-stage cervical cancer patients with high risk factors. Women who underwent radical hysterectomy and pelvic lymphadenectomy for stages IB-IIA cervical cancer and had high risk factors were enrolled. One cycle of TP was delivered before and after concurrent chemoradiotherapy, respectively. Then 3 weeks after the start of the initial cycle of the chemotherapy, patients received IMRT in a total dose of 50-50.4 Gy in 25-28 fractions with two cycles of concurrent TP, which was administered with escalating doses. Eighteen patients were enrolled at three dose levels. At dose level 1 (paclitaxel 90 mg/m(2), cisplatin 40 mg/m(2)) and level 2 (paclitaxel 90 mg/m(2), cisplatin 50 mg/m(2)), DLT (grade 3 leukopenia) was observed in one patient, respectively. At level 3 (paclitaxel 105 mg/m(2), cisplatin 50 mg/m(2)), two DLTs (grade 3 leukopenia) were observed in two patients. The MTD of paclitaxel and cisplatin was then defined as 90 and 50 mg/m(2), respectively. Pelvic IMRT and concurrent TP is a safe and tolerable adjuvant treatment regimen for cervical cancer patients with high risk factors. The MTD of concurrent chemotherapy is paclitaxel 90 mg/m(2) and cisplatin 50 mg/m(2). Trial registration Current controlled trials ChiECRCT-2014025.
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.|State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Pei
authors.initials: P
authors.lastname: Shu
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.|State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Yali
authors.initials: Y
authors.lastname: Shen
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Yaqin
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Xu
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Meng
authors.initials: M
authors.lastname: Qiu
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Qiu
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Hongfeng
authors.initials: H
authors.lastname: Gou
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Dan
authors.initials: D
authors.lastname: Cao
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Jiyan
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Cheng
authors.initials: C
authors.lastname: Yi
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Zhengyin
authors.initials: Z
authors.lastname: Liao
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Deyun
authors.initials: D
authors.lastname: Luo
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Bi
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China. wangxin213@sina.com.|State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China. wangxin213@sina.com.
authors.forename: Xin
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China. lizhiping620312@163.com.|State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, No. 37 of WainanGuoxue Lane, Chengdu, Sichuan Province, China. lizhiping620312@163.com.
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Li
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D018714:Radiotherapy, Adjuvant / Q000379:methods; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D012307:Risk Factors; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000628:therapy*
chemical_list: D017239:Paclitaxel; D002945:Cisplatin
keywords: Cervical cancer; Cisplatin; IMRT; Paclitaxel; Phase I study