None listed
Conditions
Brief summary
This study aims to evaluate the feasibility and impact of incorporating a stereotactic ablative radiotherapy (SABR) boost before definitive radiotherapy in the treatment of muscle-invasive bladder cancer (MIBC). Who is it for? You may be eligible for this study if you are a male or female, aged 18 or over, and diagnosed with muscle-invasive urothelial carcinoma of the bladder (T2-4a) of any grade. You need to be suitable for radical radiotherapy and medically inoperable or refused to undergo radical cystectomy. Study details Participants will be given SABR dose escalation of 8-10Gy in 1 single session prior to standard course of radiotherapy with or without chemotherapy. During and after the intervention, participants will be assessed for disease free survival of bladder cancer using Computer Tomography imaging of pelvis and cystoscopy examinations. Acute and late toxicities will be assessed using the grading of the National Cancer Institute Common Toxicity Criteria for Adverse Events v5.0 It is hoped that this research will improve local disease control in patients with muscle-invasive bladder cancer by evaluating the feasibility and effectiveness of incorporating a stereotactic ablative radiotherapy (SABR) boost prior to standard definitive radiotherapy.
Interventions
Delivery of SABR dose escalation of 8-10Gy in 1 single session prior to standard course of radiotherapy with or without chemotherapy.
The SABR session is prescribed by the Clinical Investigator (radiation oncologist) and delivered by the qualified radiation therapist.
SABR session takes approximately 45 minutes to deliver.
SABR session will be scheduled to occur the week prior to standard radiotherapy (at least 2 days and a maximum of 7 days between SABR and standard radiotherapy).
All treatment
Delivery of SABR dose escalation of 8-10Gy in 1 single session prior to standard course of radiotherapy with or without chemotherapy. The SABR session is prescribed by the Clinical Investigator (radiation oncologist) and delivered by the qualified radiation therapist. SABR session takes approximately 45 minutes to deliver. SABR session will be scheduled to occur the week prior to standard radiotherapy (at least 2 days and a maximum of 7 days between SABR and standard radiotherapy). All treatment will be recorded on the record and verify system of the department to ensure delivery of the treatment as per prescribed by the trial clinician.
Sponsors
South Western Sydney Local Health District
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
Histological or radiological diagnosis of muscle-invasive urothelial carcinoma of the bladder (T2-4a) of any grade. Presence or absence of pelvic nodal disease (N0-2). No signs of distant metastasis (M0). Older than 18 years. Suitable for radical radiotherapy. Medically inoperable or refused to undergo radical cystectomy. Able to provide voluntary informed consent and comply with the protocol for the duration of the study including undergoing treatment and scheduled visit and examination and follow-up.
Exclusion criteria
Distant metastasis/uncontrolled systemic disease which would preclude the patient from the study. Previous pelvic radiotherapy. Previous radical cystectomy. Other malignancy within the previous 2 years (other than adequately treated BCC of the skin or adequately treated in situ carcinoma of the cervix uteri). Previous malignancy that is likely to interfere with protocol treatment or follow up for a minimum of two years. Inflammatory bowel disease. Pregnancy. Contraindications to MRI or inability to undergo MRI scanning.
Outcome results
None listed