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PURPOSE-1

PURPOSE-1. Focus on the SPECIFIC dose-volume constraints for SPECIFIC organs-at-risk that limited the success of ‘traditional’ CRT against the common cancers. PURPOSE-2.

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PURPOSE-1

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  1. PURPOSE-1 • Focus on the SPECIFIC dose-volume constraints for SPECIFIC organs-at-risk that limited the success of ‘traditional’ CRT against the common cancers.

  2. PURPOSE-2 • Dispassionately examine the evidence from phase III studies that SRT, IMRT, PRT and HZRT have improved the quantify and/or quality of life of the patients, in comparison with ‘traditional’ CRT.

  3. EVIDENCE OF SUPERIORITY OVER CRT

  4. PURPOSE-3 • Dispassionatelydetermine the priorities and identify the opportunities for future technological development and clinical trials by answering the following key questions:

  5. KEY QUESTION 1 • The raison d’etre for the advanced technologies is to increase the dose to the cancer without increasing toxicity, or deliver the same dose as conventional technology but with less toxicity. QUESTION: In which cancers is there the most pressing need for new technology for increasing the dose or decreasing the toxicity?

  6. KEY QUESTION 2 • Demonstrating improved ANTICIPATED dose distributions (in-silico or in phantoms) only generates the hypothesis that a new technology may be superior. To prove that hypothesis, we must demonstrate - by controlled clinical trials - a clinically meaningful increase in survival and/or decrease in toxicity. QUESTION: What clinical trials are the most important for demonstrating a meaningful benefit to patients?

  7. KEY QUESTION 3 • Demonstrating improved ACTUAL dose distribution in the patient could be useful in phase I/II trials. QUESTION: What technological developments are required for demonstrating ACTUAL dose distribution in-vivo?

  8. KEY QUESTION 4 • Other clinical or biological intermediate end-points may be useful in clinical trials. QUESTION: What might those intermediate end-points be (and what lessons have we learned regarding their pitfalls from PSA, etc?)

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