Physics Bucharest 2017

RAIDER- R andomised phase II trial of A daptive I mage guided standard or D ose E scalated tumour boost R adiotherapy in the treatment of transitional cell carcinoma of the bladder

240 patients with pT2-T4a N0 M0 urothelial bladder carcinoma fulfilling eligibility criteria

RANDOMISATION 1:1:2

Group 1: Standard planning and delivery RT (control)

Group 2: Adaptive image guided Tumour focused RT (SART)

Group 3: Adaptive image guided Dose escalated Tumour boost RT (DART) 70Gy/32f cohort n=60 60Gy/20 f cohort n=60

Joint protocol UK NCRI and TROG

64GY32f cohort n=30 55Gy/20 f cohort n=30

64GY32f cohort n=30 55Gy/20 f cohort n=30

PRIMARY ENDPOINT Stage I: Proportion of patients meeting radiotherapy dose constraints to bladder, bowel & rectum in DART groups. Stage II: Proportion of patients experiencing any ≥G3 Common Terminology Criteria for Adverse Events (CTCAE) v.4 late toxicity (6-18 months post radiotherapy).