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Active, Not Recruiting

NCT Number: NCT02447549

Study of Tumour Focused Radiotherapy for Bladder Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age ≥16 years
  • Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder
  • Unifocal bladder TCC staged T2-T4a N0 M0*
  • Fit to receive a radical course of radiotherapy
  • WHO performance status 0-2
  • Willing and able to comply with study procedures and follow up schedule *Tumour location must be clearly visible on imagine or recorded on a surgical bladder map

Exclusion criteria

  • Nodal or metastatic disease
  • Multifocal invasive disease
  • Simultaneous TCC in upper tract or urethra
  • Pregnancy
  • Active malignancy within 2 years of randomisation (not including non melanomatous skin carcinoma, previous non muscle invasive bladder tumours, NCCN low risk prostate cancer (T1/T2a, Gleason 6 PSA <10), in situ carcinoma of any site)
  • Bilateral hip replacements
  • Any other conditions that in the Principal Investigator's opinion would be a contra-indication to radiotherapy (e.g. previous pelvic radiotherapy / inflammatory bowel disease)

Treatment and study plan

WBRT

Radiation

One RT plan with whole bladder treated to standard dose.

SART

Radiation

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.

DART

Radiation

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.

Primary outcomes

  1. Proportion of participants meeting predefined radiotherapy dose constraints in DART group

    Time frame: 4-6 weeks from randomisation

    Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.

  2. Proportion of patients experiencing severe late side effects following radiotherapy.

    Time frame: 6-18 months post radiotherapy

    Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.

Secondary outcomes

  1. Clinician reported acute toxicity

    Time frame: 0-6 months post radiotherapy

    CTCAE v4

  2. Patient reported outcomes- symptomatic toxicity

    Time frame: 0-24 months post radiotherapy

    Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire

  3. Patient reported outcomes- urinary side effects

    Time frame: 0-24 months post radiotherapy

    King's Health Questionnaire (KHQ)

  4. Patient reported outcomes- sexual function

    Time frame: 0-24 months post radiotherapy

    excerpt of the EORTC QLQ-BLM30 questionnaire

  5. Patient reported outcomes- chronic gastrointestinal symptoms

    Time frame: 0-24 months post radiotherapy

    Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire

  6. Patient reported outcomes- health status

    Time frame: 0-24 months post radiotherapy

    EQ-5D questionnaire

  7. Loco-regional MIBC control

    Time frame: 0-5 years post radiotherapy

    Control of existing MIBC

  8. Progression free survival

    Time frame: 0-5 years post radiotherapy

    Freedom from progressive disease

  9. Overall survival

    Time frame: 0-5 years post radiotherapy

    Death from any cause

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Trans Tasman Radiation Oncology Group

Registry information

Official study 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

Acronym: RAIDER

Important dates

Study start
2015
Primary completion
2021
Study completion
2029
First posted
May 19, 2015
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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