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Page Background

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).