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Phase I/II Study to Evaluate Feasibility and Validation of Intensity
Modulated Radiation Therapy for Prostate Cancer at High-Dose Levels
The Phase I portion of this study is to identify acute and late
GU and GI toxicities associated with intensity modulated radiation
therapy (IMRT) delivered at high doses. The goal is to confirm
safety data reported by Phase I/II data from Memorial Sloan Kettering
Cancer Center, New York. Acute toxicity is defined to occur within
90 days from the start of radiotherapy treatment and late toxicity
occurs after 90 days. The objectives are to validate the data reported
by a major academic center regarding the use of high dose IMRT
for prostate cancer in the community setting; to quantify the normal
tissue toxicity rate for rectum and bladder using IMRT at the high-dose
levels and to evaluate local control by clinical and PSA (stable
in normal range) determinations.
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