Bladder Cancer Clinical Trial
Official title:
A Randomised Phase II Trial of Adaptive Image Guided Standard or Dose Escalated Tumour Boost Radiotherapy in the Treatment of Transitional Cell Carcinoma of the Bladder
Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed
in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the
bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually
treated either with surgical removal of the bladder, or daily radiotherapy treatment (high
strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate
methods which have the potential to improve how well this radiotherapy works.
RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single
UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout
treatment and treats the whole bladder with the same radiotherapy dose. In adaptive
radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused
radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder.
In RAIDER, at least 240 participants with muscle invasive bladder cancer will be in one of 3
treatment groups:
1. standard whole bladder radiotherapy
2. standard dose tumour focused adaptive radiotherapy
3. dose escalated tumour boost adaptive radiotherapy
Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after
radiotherapy and annually thereafter to check whether the cancer has returned and to receive
treatment for any symptoms they may be experiencing.
RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher
radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and
to check that the long term side effects of the treatment are acceptable. If this is the
case, results of RAIDER will be used to develop a study to establish whether dose escalated
radiotherapy is better at treating bladder cancer than standard dose.
RAIDER has a two stage design. Stage 1 will establish the feasibility of delivering DART in a
multi-centre setting, and stage 2 will establish the toxicity of DART. 72 patients will be
recruited in stage 1, with at least an additional 168 patients in stage 2 (sufficient to
recruit 57 evaluable participants to the DART group in each fractionation cohort).
Both fractionation regimens in standard use in UK are included - 32f and 20f. Participants
will be permitted to receive concomitant chemotherapy. Primary endpoints will be assessed in
each fractionation cohort separately with the flexibility to drop either a fractionation
cohort or an experimental treatment group (on advice of Independent Data Monitoring
Committee) following completion of stage 1.
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