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NCT02388932 · OUTCOME

Maximum Tolerated Dose (MTD) of Head and Neck SBRT

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.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
3 months

What was measured

Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.

Analysis population: 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.

Groups in this outcome

Treatment (SBRT)

Patients 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 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. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (SBRT)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      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
  1. description
    Patients 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 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. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    id
    OG000
    title
    Treatment (SBRT)
population Description
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.
reporting Status
POSTED
time Frame
3 months
title
Maximum Tolerated Dose (MTD) of Head and Neck SBRT
type
PRIMARY

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

Preserved source evidence · Not medical advice