Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT
I. To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose
I. To investigate the dosimetric tolerance of normal structures to reirradiation with the
pulsed low dose rate technique.
II. To determine the palliative efficacy and quality of life in patients treated on this
III. To determine duration of response and time to progression.
OUTLINE: This is a dose-escalation study.
Patients undergo 3-dimensional CRT or IMRT once daily (QD), 5 days a week for 10-30 days.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every month for 6 months and
then every 12 weeks thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD)
To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique. The MTD is defined as the dose level closest to, but not over that which is predicted to result in a DLT rate of 20%, the target toxicity rate. A dose limiting toxicity (DLT) is a grade ≥ 4 acute or grade ≥ 3 late toxicity of an organ system within the reirradiation field.
During re-irradiation treatment through 30 days of completion of treatment
C-M Charlie Ma, PhD
Fox Chase Cancer Center
United States: Institutional Review Board
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