None listed
Conditions
Brief summary
The study is evaluating the feasibility and toxicity of the refined bladder adaptive radiotherapy (BART) protocol. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have histologically confirmed muscle invasive bladder cancer (any pathology), stage T2-3b N0 M0, considered suitable for definitive radiotherapy with or without concurrent chemotherapy, an ECOG performance status score of 2 or less, have a life expectancy greater than 5 years, and available for follow-up. Trial details Participants in this study will be administered Bladder adaptive radiotherapy (BART). BART is a specialized technique that utilizes computed tomography (CT) scans to visualize the bladder, and therefore allow optimal matching of a radiotherapy treatment plan on a daily basis. Adaptive radiotherapy is particularly useful in the treatment of bladder cancer, given the significant daily variability in the location and size of the bladder. The technique of daily optimization of treatment plans allows smaller volumes to be treated and therefore less toxicity to surrounding normal organs (such as small & large bowel). The dosage amount and frequency of radiotherapy administered in this trial will not differ from standard ‘non-adaptive’ treatment that you would otherwise receive if you declined participation in the trial. These parameters will be determined by your Radiation Oncologist. In the large majority of cases, radiotherapy will be given as 5 treatments per week (daily from Monday to Friday), as part of a 4-7 week treatment course. The duration of radiotherapy treatment will be determined by your Radiation Oncologist, but will generally range from 4-7 weeks. Follow-up review will be conducted by treating Radiation Oncology team at 4-6 weeks after completion of radiotherapy, and at 6, 12, 18, and 24 months post-treatment.
Interventions
What is BART and what does it involve?
Radiotherapy uses high-energy radiation to kill cancer cells by damaging their DNA.
Bladder adaptive radiotherapy (BART) is a specialized technique that utilizes computed tomography (CT) scans to visualize the bladder, and therefore allow optimal matching of a radiotherapy treatment plan on a daily basis. Adaptive radiotherapy is particularly useful in the treatment of bladder cancer, given the significant daily variability in the location and size of the
What is BART and what does it involve? Radiotherapy uses high-energy radiation to kill cancer cells by damaging their DNA. Bladder adaptive radiotherapy (BART) is a specialized technique that utilizes computed tomography (CT) scans to visualize the bladder, and therefore allow optimal matching of a radiotherapy treatment plan on a daily basis. Adaptive radiotherapy is particularly useful in the treatment of bladder cancer, given the significant daily variability in the location and size of the bladder. The technique of daily optimization of treatment plans allows smaller volumes to be treated and therefore less toxicity to surrounding normal organs (such as small & large bowel). The dosage amount and frequency of radiotherapy administered in this trial will not differ from standard ‘non-adaptive’ treatment that you would otherwise receive if you declined participation in the trial. These parameters will be determined by your Radiation Oncologist. In the large majority of cases, radiotherapy will be given as 5 treatments per week (daily from Monday to Friday), as part of a 4-7 week treatment course. BOLART refers to an ongoing study of adaptive image-guided radiotherapy for muscle invasive bladder cancer that is being carried out by the Trans-Tasman Radiation Oncology Group. We have adapted the BOLART protocol to allow the adaptive radiotherapy technique to commence from day 1 rather than day 8. This adjustment allows the benefits of adaptive radiotherapy to be realised earlier on in the treatment. We have also modified from BOLART the method of optimization of treatment plans, which we theorise from our experience should allow easier and tighter matching to the ‘best fit of the day’. The duration of radiotherapy treatment will be determined by your Radiation Oncologist, but will generally range from 4-7 weeks. Follow-up review will be conducted by treating Radiation Oncology team at 4-6 weeks after completion of radiotherapy, and at 6, 12, 18, and 24 months post-treatment.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or older Histologically confirmed muscle invasive bladder cancer (any pathology) Stage T2-3b N0 M0 Considered suitable for definitive radiotherapy with or without concurrent chemotherapy Has provided written Informed Consent for participation in this trial An ECOG performance status score of 2 or less Life expectancy greater than 5 years Participants capable of childbearing are using adequate contraception Available for follow up
Exclusion criteria
Other active malignancy Previous pelvic radiotherapy Clinical or radiological evidence of nodal or distant metastases Women who are pregnant or lactating
Outcome results
None listed