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Title: Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)

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 notmore » 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.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [6];  [8];  [9]; ;  [1];  [9]
  1. Institute of Cancer Research (United Kingdom)
  2. University of Liverpool (United Kingdom)
  3. Gloucestershire Hospitals NHSFT (United Kingdom)
  4. South Devon Healthcare NHSFT (United Kingdom)
  5. Brighton and Sussex University Hospitals (United Kingdom)
  6. Royal Devon and Exeter NHSFT (United Kingdom)
  7. University Hospital of North Staffordshire NHS Trust (United Kingdom)
  8. Clatterbridge Cancer Centre NHSFT (United Kingdom)
  9. University of Birmingham (United Kingdom)
Publication Date:
OSTI Identifier:
22267879
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 87; Journal Issue: 2; Other Information: Copyright (c) 2013 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BLADDER; CHEMOTHERAPY; MUSCLES; NEOPLASMS; RADIATION DOSES; RADIOTHERAPY; SIDE EFFECTS; TOXICITY

Citation Formats

Huddart, Robert A., E-mail: robert.huddart@icr.ac.uk, Hall, Emma, Hussain, Syed A., Jenkins, Peter, Rawlings, Christine, Tremlett, Jean, Crundwell, Malcolm, Adab, Fawzi A., Sheehan, Denise, Syndikus, Isabel, Hendron, Carey, Lewis, Rebecca, Waters, Rachel, and James, Nicholas D. Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004). United States: N. p., 2013. Web. doi:10.1016/J.IJROBP.2013.06.2044.
Huddart, Robert A., E-mail: robert.huddart@icr.ac.uk, Hall, Emma, Hussain, Syed A., Jenkins, Peter, Rawlings, Christine, Tremlett, Jean, Crundwell, Malcolm, Adab, Fawzi A., Sheehan, Denise, Syndikus, Isabel, Hendron, Carey, Lewis, Rebecca, Waters, Rachel, & James, Nicholas D. Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004). United States. https://doi.org/10.1016/J.IJROBP.2013.06.2044
Huddart, Robert A., E-mail: robert.huddart@icr.ac.uk, Hall, Emma, Hussain, Syed A., Jenkins, Peter, Rawlings, Christine, Tremlett, Jean, Crundwell, Malcolm, Adab, Fawzi A., Sheehan, Denise, Syndikus, Isabel, Hendron, Carey, Lewis, Rebecca, Waters, Rachel, and James, Nicholas D. 2013. "Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)". United States. https://doi.org/10.1016/J.IJROBP.2013.06.2044.
@article{osti_22267879,
title = {Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)},
author = {Huddart, Robert A., E-mail: robert.huddart@icr.ac.uk and Hall, Emma and Hussain, Syed A. and Jenkins, Peter and Rawlings, Christine and Tremlett, Jean and Crundwell, Malcolm and Adab, Fawzi A. and Sheehan, Denise and Syndikus, Isabel and Hendron, Carey and Lewis, Rebecca and Waters, Rachel and James, Nicholas D.},
abstractNote = {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.},
doi = {10.1016/J.IJROBP.2013.06.2044},
url = {https://www.osti.gov/biblio/22267879}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 2,
volume = 87,
place = {United States},
year = {Tue Oct 01 00:00:00 EDT 2013},
month = {Tue Oct 01 00:00:00 EDT 2013}
}