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A randomized non-inferiority trial of reduced high dose volume versus standard volume radiotherapy for muscle-invasive bladder cancer : results of the BC2001 trial (CRUK/01/004)
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Huddart, Robert A., Hall, E., Hussain, S. A., Jenkins, P., Rawlings, C. J., Tremlett, J., Crundwell, M., Adab, F., Sheehan, D., Syndikus, Isabel, Hendron, C., Lewis, R., Waters, R. and James, Nicholas D. (2013) A randomized non-inferiority trial of reduced high dose volume versus standard volume radiotherapy for muscle-invasive bladder cancer : results of the BC2001 trial (CRUK/01/004). International Journal of Radiation : Oncology - Biology - Physics, 87 (2). pp. 261-269. doi:10.1016/j.ijrobp.2013.06.2044 ISSN 0360-3016.
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Official URL: http://dx.doi.org/10.1016/j.ijrobp.2013.06.2044
Abstract
PURPOSE:
To test whether reducing radiation dose to uninvolved bladder while maintaining dose to the tumor would reduce side effects without impairing local control in the treatment of muscle-invasive bladder cancer.
METHODS AND MATERIALS:
In this phase III multicenter trial, 219 patients were randomized to standard whole-bladder radiation therapy (sRT) or reduced high-dose volume radiation therapy (RHDVRT) that aimed to deliver full radiation dose to the tumor and 80% of maximum dose to the uninvolved bladder. Participants were also randomly assigned to receive radiation therapy alone or radiation therapy plus chemotherapy in a partial 2 × 2 factorial design. The primary endpoints for the radiation therapy volume comparison were late toxicity and time to locoregional recurrence (with a noninferiority margin of 10% at 2 years).
RESULTS:
Overall incidence of late toxicity was less than predicted, with a cumulative 2-year Radiation Therapy Oncology Group grade 3/4 toxicity rate of 13% (95% confidence interval 8%, 20%) and no statistically significant differences between groups. The difference in 2-year locoregional recurrence free rate (RHDVRT - sRT) was 6.4% (95% confidence interval -7.3%, 16.8%) under an intention to treat analysis and 2.6% (-12.8%, 14.6%) in the "per-protocol" population.
CONCLUSIONS:
In this study RHDVRT did not result in a statistically significant reduction in late side effects compared with sRT, and noninferiority of locoregional control could not be concluded formally. However, overall low rates of clinically significant toxicity combined with low rates of invasive bladder cancer relapse confirm that (chemo)radiation therapy is a valid option for the treatment of muscle-invasive bladder cancer.
Item Type: | Journal Article | ||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Cancer Research Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | International Journal of Radiation : Oncology - Biology - Physics | ||||||
Publisher: | Elsevier Science Inc. | ||||||
ISSN: | 0360-3016 | ||||||
Official Date: | 1 October 2013 | ||||||
Dates: |
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Volume: | 87 | ||||||
Number: | 2 | ||||||
Page Range: | pp. 261-269 | ||||||
DOI: | 10.1016/j.ijrobp.2013.06.2044 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) |
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