A Phase 2 interventional study of WBRT and SART in Bladder Cancer, sponsored by Institute of Cancer Research, United Kingdom. Active, not recruiting at 49 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Institute of Cancer Research, United Kingdom · Phase 2, Interventional, and Treatment
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:
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 345 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard dose whole bladder radiotherapy
Radiation: WBRT
Standard dose Adaptive tumour focused radiotherapy (SART)
Radiation: SART
Dose escalated Adaptive tumour boost radiotherapy (DART)
Radiation: DART
One RT plan with whole bladder treated to standard dose.
Three plans (small, medium \& large) generated with the standard dose of RT focused on the tumour, sparing the normal bladder from full dose radiation. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.
Three plans (small, medium \& large) generated with a higher dose than standard focused on the tumour and the remainder of the bladder treated to the same dose as in the SART group. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.
Proportion of participants meeting predefined radiotherapy dose constraints in DART group
Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.
Time frame: 4-6 weeks from randomisation
Proportion of patients experiencing severe late side effects following radiotherapy.
Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.
Time frame: 6-18 months post radiotherapy
Clinician reported acute toxicity
CTCAE v4
Time frame: 0-6 months post radiotherapy
Patient reported outcomes- symptomatic toxicity
Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire
Time frame: 0-24 months post radiotherapy
Patient reported outcomes- urinary side effects
King's Health Questionnaire (KHQ)
Time frame: 0-24 months post radiotherapy
Patient reported outcomes- sexual function
excerpt of the EORTC QLQ-BLM30 questionnaire
Time frame: 0-24 months post radiotherapy
Patient reported outcomes- chronic gastrointestinal symptoms
Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire
Time frame: 0-24 months post radiotherapy
Patient reported outcomes- health status
EQ-5D questionnaire
Time frame: 0-24 months post radiotherapy
Loco-regional MIBC control
Control of existing MIBC
Time frame: 0-5 years post radiotherapy
Progression free survival
Freedom from progressive disease
Time frame: 0-5 years post radiotherapy
Overall survival
Death from any cause
Time frame: 0-5 years post radiotherapy
This study is active, not recruiting, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Institute of Cancer Research, United Kingdom