Participant flow

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer · Source last updated 2019-01-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.

   id

   FG000

   title

   Treatment (SBRT)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice