{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.","groups":[{"description":"Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days.\n\nThree dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 patients allocated to them. All patients are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 patient experiences a DLT, patients will be enrolled at the next dose level. If ≥3 patients experience a DLT, further accrual will be permanently halted and the study stopped. If 2 patients experience a DLT, then an additional 6 patients will be enrolled at the same dose level. In this setting, if ≤ 3/12 patients have a DLT, patients will be enrolled at the next dose level. If ≥ 4/12 patients have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe.\n\nThe dosing strategy for the 2nd (45Gy) cohort will be identical to the first.","id":"OG000","title":"Treatment (SBRT)"}],"populationDescription":"Patients who received treatment. MTD was not able to be determined because only three patients enrolled and no DLTs were observed. A recommended MTD could only be made if enough patients had accrued to assess toxicities in the different dosage levels.","reportingStatus":"POSTED","timeFrame":"3 months","title":"Maximum Tolerated Dose (MTD) of Head and Neck SBRT","type":"PRIMARY"}