Radiotherapy vs Surgery in the treatment of Bladder Cancer Patients

• Research type

  Research Study

• Full title

  Comparative Clinical Effectiveness of Radiotherapy and Surgery for the Treatment of Patients with Clinically Localised Muscle Invasive Bladder Cancer

• IRAS ID

  203500

• Contact name

  Zafer Tandogdu

• Contact email

  zafer.tandogdu@ncl.ac.uk

• Sponsor organisation

  Newcastle University

• Duration of Study in the UK

  0 years, 8 months, 8 days

• Research summary

  1. Aims
  In this study the aim is to conduct a comparison of main treatment options (radiotherapy & surgery) of bladder cancer at the stage where the cancer grown into or beyond the muscle layer of the bladder but has not spread to other parts of the body.

  2. Background
  Bladder cancer is an important health problem being the most frequent tumour of the urinary tract. It becomes universally fatal without treatment when it grows into the underlying muscle (muscle invasive bladder cancer; MIBC) and even with modern treatment 50% of people die of their disease with five years. The two potentially curative treatment options for patients with MIBC are surgery to remove the bladder and radiotherapy. Giving chemotherapy before surgery or radiotherapy, or combining it with radiotherapy, can help these treatments work better. This work will use the information we have in a novel way to predict which option is best for particular patient circumstances.
  
  3. Methods

  Understanding the true effect of a treatment can be done by comparison of treatments amongst groups that are similar with each other. However, as it is with the current cancer registry, characteristics of treatment groups gathered from registries are highly likely to be dissimilar. This problem can be mitigated by utilizing specific statistical techniques (propensity score matching). The process is carried out by; (i) identifying variables that influence treatment outcomes, (ii) balancing and matching the treatment groups according to these variables and (iii) finally carrying out the comparisons based on the balanced groups. We have already identified the variables that influence treatment outcomes through a Delphi process with an international expert panel of bladder cancer. Subsequent to balancing the matched treatment groups will be compared for the following outcomes: time to death (due to cancer, other diseases, treatment (within 90 days of primary treatment)), time to recurrence and additional treatments required.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  16/NE/0212

• Date of REC Opinion

  6 Jul 2016

• REC opinion

  Favourable Opinion