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
Joint protocol
UK NCRI and
TROG
240 patients with pT2-T4a N0 M0
urothelial bladder carcinoma fulfilling
eligibility criteria
Group 1:
Standard planning
and delivery RT
(control)
64GY32f cohort n=30
55Gy/20 f cohort n=30
RANDOMISATION
1:1:2
Group 2:
Adaptive image
guided Tumour
focused RT (SART)
64GY32f cohort n=30
55Gy/20 f cohort n=30
Group 3:
Adaptive image
guided Dose escalated
Tumour boost RT
(DART)
70Gy/32f cohort n=60
60Gy/20 f cohort n=60
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).