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• W2093583396 endingPage "141" @default.
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• W2093583396 abstract "The purpose of this review is to evaluate the methodology used in published phase I radiotherapy (RT) dose escalation trials. A specific emphasis was placed on the frequency of reporting late complications as endpoint.We performed a systematic literature review using a predefined search strategy to identify all phase I trials reporting on external radiotherapy dose escalation in cancer patients.Fifty-three trials (phase I: n = 36, phase I-II: n = 17) fulfilled the inclusion criteria. Of these, 20 used a modified Fibonacci design for the RT dose escalation, but 32 did not specify a design. Late toxicity was variously defined as > 3 months (n = 43) or > 6 months (n = 3) after RT, or not defined (n = 7). In only nine studies the maximum tolerated dose (MTD) was related to late toxicity, while only half the studies reported the minimum follow-up period for dose escalation (n = 26).In phase I RT trials, late complications are often not taken into account and there is currently no consensus on the methodology used for radiation dose escalation studies. We therefore propose a decision-tree algorithm which depends on the endpoint selected and whether a validated early surrogate endpoint is available, in order to choose the most appropriate study design." @default.
• W2093583396 created "2016-06-24" @default.
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• W2093583396 date "2010-05-01" @default.
• W2093583396 modified "2023-10-17" @default.
• W2093583396 title "A systematic methodology review of phase I radiation dose escalation trials" @default.
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• W2093583396 doi "https://doi.org/10.1016/j.radonc.2010.02.009" @default.

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