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Pneumonitis and fibrosis after 3-dimensional conformal high-dose radiation are reviewed, including recent updates from radiation dose escalation trials.
The purpose of this review is to evaluate the methodology used in published phase I radiotherapy (RT) dose escalation trials.
Preclinical studies of the type described in this report must be combined with surrogate imaging agents to establish safe starting activity levels for phase I dose escalation trials.
However, few dose escalation trials planned to incorporate M&S into decision making.
Dose limiting toxicities were observed in dose escalation trials but a maximum tolerated dose was not established.
Dose escalation trials in pretreated populations of MM patients proved promising, but with higher rates of severe AEs reported in the carfilzomib study.
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Design: Randomized, controlled, single-blind phase II dose escalation trial.
Design: Controlled, single-blind, parallel-group phase II dose escalation trial.
This was a dose escalation trial designed to determine the safety and tolerability of intracoronary rhVEGF infusions.
We present a Phase I dose escalation trial design based on a modified continual reassessment method that allows for sharing of information between populations.
Based on these studies, we proposed a phase 1 dose escalation trial followed by a phase 2 randomized, double-blind, placebo-controlled clinical trial of human MSCs for the treatment of moderate-severe ARDS.
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