title: Dose escalation of Stereotactic Body Radiotherapy (SBRT) for locally advanced unresectable pancreatic cancer patients with CyberKnife: protocol of a phase I study.
abstract: BACKGROUND
  Dose escalation of SBRT for locally advanced pancreatic cancer patients had been reported in several studies in one or three fractions, and phase I protocol was developed to investigate the maximum tolerated dose with CyberKnife for locally advanced unresectable pancreatic cancer patients in five fractions.
  
  
  METHODS
  The study is designed as a mono-center phase I study. The primary endpoint is to determine the maximum tolerated dose by frequency of III/IV GI (gastrointestinal) toxicity. Adverse events (AE) according to Common Toxicity Criteria (CTC) version 4. Doses of 7 Gy, 7.5 Gy, 8 Gy, 8.5 Gy, 9 Gy, 9.5Gy x 5 respectively would be delivered while meeting with normal tissue constraints. A minimum of three patients will be included for each dosage level. And an interval is 4 weeks from the first patient treatment to the next patient treatment at each dose level. The maximal tolerated dose will be defined as the dose for which at least two patients in three, or at least three patients in nine, will present with a limiting toxicity.
  
  
  CONCLUSIONS
  Since the dose and fractions of SBRT treatment for locally advanced pancreatic cancer patients are still unknown, we propose to conduct a Phase I study determining the maximum tolerated dose of CyberKnife SBRT for the treatment of locally advanced pancreatic tumor based on a 5 fractions treatment regimen. This trial protocol has been approved by the Ethics committee of Changhai hospital. The ethics number is 2016-030-01.
  
  
  BACKGROUND
  Clinical trials number: NCT02716207 . Date of registration: 20 March 2016.
authors.affiliation: Department of Radiation Oncology, Changhai Hospital, No.168 Changhai road, Shanghai, China.
authors.forename: Shui-Wang
authors.initials: SW
authors.lastname: Qing
authors.affiliation: Department of Radiation Oncology, Changhai Hospital, No.168 Changhai road, Shanghai, China.
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Ju
authors.affiliation: Department of Radiation Oncology, Changhai Hospital, No.168 Changhai road, Shanghai, China.
authors.forename: Yang-Sen
authors.initials: YS
authors.lastname: Cao
authors.affiliation: Department of Radiation Oncology, Changhai Hospital, No.168 Changhai road, Shanghai, China. correspondzhj@163.com.
authors.forename: Huo-Jun
authors.initials: HJ
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000532:radiotherapy*; D016634:Radiosurgery / Q000379:methods*; D011879:Radiotherapy Dosage; D012107:Research Design; D017321:Clinical Trials, Phase I as Topic
keywords: Locally advanced pancreatic cancer; SBRT study protocol