At the moment the best treatment for controlling bladder cancer remains to be determined. Bladder cancer may be controlled by surgical removal but in some patients the cancer may come back and further surgery will be needed. Bladder cancer can be treated without major surgery by giving radiotherapy to the whole bladder.
But this radiotherapy treatment can cause permanent shrinkage of the bladder and does not always control the cancer. This may result in half of the patients treated having surgery to remove the bladder, known as a salvage cystectomy. It is important to try and preserve the bladder as much as possible when treating the cancer as this will improve patients' quality of life.
Standard radiotherapy treatment involves giving radiotherapy to the whole bladder. However, it is not known whether it is necessary to treat the whole bladder or whether we can just treat the tumour alone. Results from other studies, including a large, randomised, controlled trial in prostate cancer, have shown that shielding normal tissue from radiotherapy can reduce late side effects. It is now necessary to test this reduced volume treatment in bladder cancer.
Chemotherapy combined with Radiotherapy Vs Radiotherapy Alone
Studies have been carried out on people with cancers found in other areas of the body (anal, head and neck, cervix cancer). These studies looked at the effectiveness and the side effects caused by giving chemotherapy combined with radiotherapy instead of just giving radiotherapy alone. Small studies in bladder cancer patients have shown that this combined chemoradiotherapy treatment has better results than those seen with radiotherapy alone.
However, these studies are too small and not enough patients were treated to see if the improvement seen would be true for all patients treated. It is now necessary to test this chemoradiotherapy treatment again in a large, randomised study. The chemotherapy drugs that will be combined with the radiotherapy in the BC2001 trial are 5-FU and mitomycin.