Non-muscle invasive bladder cancer is common and can cause substantial suffering. If the cancer is “high risk” then in over 30% of people it can turn into a more aggressive form of bladder cancer that requires treatment such as removal of or radiotherapy to the bladder within 5 years despite best current treatment. This risk can be reduced by placing BCG bacteria into the bladder. Recent preliminary studies show promising results from also placing mitomycin, a chemotherapy drug, into the bladder along with BCG treatment. This large-scale, randomised trial will determine the effects of adding mitomycin to BCG on cure rates, survival, side effects, and quality of life.
Urothelial transitional cell cancer (uTCC) is a type of cancer that typically starts in the cells that line the inside of the urinary system: the bladder, parts of the kidney, and associated structures such as the ureters which are the tubes connecting the kidneys to the bladder. People with “advanced or metastatic urothelial cancer” have cancer which has spread beyond the region of the urinary system, typically to lymph nodes, the wall of abdomen or pelvis, bones or other organs. Chemotherapy is commonly used in this situation. The two commonest types of chemotherapy used initially (“first-line”) use the drugs Gemcitabine and Cisplatin (referred to as GC), or methotrexate, vinblastine, doxorubicin and cisplatin (MVAC). These are called “platinum-based” treatments. Some patients need further chemotherapy if the cancer comes back or worsens. There is no good evidence showing a benefit of one type of chemotherapy over any other in this “second-line” setting. Chemotherapy drugs of a type called Taxanes have commonly been used as a second line treatment. This family of chemotherapy drugs include Nab-Paclitaxel and Paclitaxel.
This study has been designed to look at whether Nab-Paclitaxel improves survival and is less toxic with improved quality of life compared with Paclitaxel in people with advanced or metastatic urothelial cancer, in the setting where the cancer has grown or come back during or within 12 months of completion of platinum based chemotherapy.
This trial is now closed to recruitment.
This trial is aimed at managing bladder cancer that has spread into the wall of the bladder. A combination of chemotherapy and radiotherapy is the current standard treatment . This study aims to assess if it is safe and effective to add an additional new drug called pembrolizumab to the standard therapy of chemotherapy and radiation therapy.
Pembrolizumab is a new treatment that “takes the brakes off” the immune system, allowing it to attack cancers more effectively. Studies of pembrolizumab in widespread bladder cancer has shown benefit, with cancer shrinkage observed in about two thirds of people, and in some cases long periods of disease control. At present, Pembrolizumab, is approved for use in Australia for the treatment of advanced melanoma in adults.
Non-muscle invasive bladder cancer (NMIBC) makes up approximately 70-80% of all bladder cancer diagnoses. Treatment is generally intended to reduce the risk of the bladder cancer recurring or progressing to muscle invasive disease. Treatment involves endoscopic resection to the bladder tumours followed by potential intravesical chemotherapy or immunotherapy. Although treatments can significantly reduce the risk of recurrence and progression, there are both benefits and harms that are likely to vary between treatment options. However, little is known about the impact of these treatments on patients’ quality of life.
This project follows on from Phase I, which involved qualitative research to develop a draft Non-Muscle Invasive Bladder Cancer Symptom Index (NMIBC-SI). The aim of the current project is to evaluate the psychometric properties of the NMIBC-SI. This will be conducted across two field tests:
- Field Test 1 is a cross-sectional study design asking participants to complete the draft NMIBC-SI questionnaire either on paper or electronically. The purpose of field test 1 is to produce a shorter version of the NMIBC-SI by eliminating items with poor psychometric properties.
- Field test 2 uses a prospective longitudinal study design to evaluate the clinical validity of the final version of the NMIBC-SI. Participants will be asked to complete the NMIBC-SI along with comparative questionnaires at different time-points during their treatment. The purpose of Field Test 2 is to assess the reliability, validity and responsiveness of the final version of the NMIBC-SI to ensure that it is fit for purpose in clinical research.