Publications Repository

Publications Repository

View item 
  •   Home
  • ICR Divisions
  • Clinical Studies
  • View item
  • Home
  • ICR Divisions
  • Clinical Studies
  • View item
JavaScript is disabled for your browser. Some features of this site may not work without it.

A road map for designing phase I clinical trials of radiotherapy-novel agent combinations.

Thumbnail
View/Open
ccr-21-4087.pdf (534.4Kb)
Date
2022-05-12
ICR Author
Hall, Emma
Author
Brown, SR
Hinsley, S
Hall, E
Hurt, C
Baird, RD
Forster, M
Scarsbrook, AF
Adams, RA
Show allShow less
Type
Journal Article
Metadata
Show full item record
Abstract
Radiotherapy has proven efficacy in a wide range of cancers. There is growing interest in evaluating radiotherapy-novel agent combinations, and a drive to initiate this earlier in clinical development of the novel agent, where scientific rationale and pre-clinical evidence for a radiotherapy combination approach is high. Optimal design, delivery and interpretation of studies is essential. In particular, design of phase I studies to determine safety and dosing are critical to an efficient development strategy. There is significant interest in early phase research amongst scientific and clinical communities over recent years, at a time when scrutiny of trials methodology has significantly increased. To enhance trial design, optimize safety, and promote efficient trial conduct, this position paper reviews the current phase I trial design landscape. Key design characteristics extracted from 37 methodology papers were used to define a road map and design selection process for phase I radiotherapy-novel agent trials. Design selection is on the basis of single or dual therapy dose escalation, dose limiting toxicity categorisation, maximum tolerated dose determination, subgroup evaluation, software availability and design performance. Fifteen of 37 designs were identified as being immediately accessible and relevant to radiotherapy-novel agent phase I trials. Applied examples of using the road map are presented. Developing these studies is intensive, highlighting the need for funding and statistical input early in trial development to ensure appropriate design and implementation from the outset. Application of this road map will improve design of phase I radiotherapy-novel agent combination trials, enabling a more efficient development pathway.
URI
https://repository.icr.ac.uk/handle/internal/5237
DOI
https://doi.org/10.1158/1078-0432.CCR-21-4087
https://doi.org/10.1158/1078-0432.CCR-21-4087
 
Collections
  • Clinical Studies
Research team
Clin Trials & Stats Unit
Language
eng
Date accepted
2022-04-28
License start date
2022-05-12
Citation
Clinical Cancer Research, 2022, pp. clincanres.4087.2021 -
Publisher
American Association for Cancer Research (AACR)

Browse

All of ICR repositoryICR DivisionsBy issue dateAuthorsTitlesPublication TypesThis collectionBy issue dateAuthorsTitlesPublication Types
  • Login
  • Registered office: The Institute of Cancer Research, 123 Old Brompton Road, London, SW7 3RP
    A Charity, Not for Profit. Company Limited by Guarantee.
    Registered in England No. 534147. VAT Registration No. GB 849 0581 02.