Shein-Chung Chow, Yu-Wei Chang
Statistical considerations for rare diseases drug development
Journal of biopharmaceutical statistics
spatially fractionated radiation therapy sfrt increasingly used bulky advanced tumors specifics clinical sfrt practice remain elusive study aimed determine practice patterns grid lattice radiation therapy lrtbased sfrt survey designed identify radiation oncologists practice patterns patient selection sfrt dosingplanning dosimetric parameter use sfrt platformstechniques combinations sfrt conventional external beam radiation therapy cert multimodality therapies physicists technical implementation delivery quality procedures data summarized using descriptive statistics group comparisons analyzed permutation tests majority practicing radiation oncologists united states 100 global 727 considered sfrt accepted standardofcare radiation therapy option bulkyadvanced tumors treatment metastasesrecurrences nonmetastatic primary tumors predominantly head neck lung cancer sarcoma commonly practiced palliative sfrt regimens 15 18 gy1 fraction predominated 513 curativeintent treatment nonmetastatic tumors 15 gy1 fraction 280 fractionated sfrt 240 common sfrt combined cert commonly always palliative 786 curativeintent 857 treatment sfrtcert time sequencing cert dose adjustments variable curativeintent treatment concurrent chemotherapy immunotherapy found acceptable 545 286 respectively use sfrt dosimetric parameters highly variable differed grid lrt sfrt heterogeneity dosimetric parameters commonly used p 008 commonly thought influence local control peak dose p 008 lrt grid therapy sfrt already evolved clinical practice pattern advancedbulky tumors major treatment approaches consistent follow literature sfrtcert combinationsequencing clinical utilization dosimetric parameters variable areas may benefit targeted education standardization knowledge gaps may filled incorporating identified inconsistencies future clinical research