
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the chemotherapy drugs cabazitaxel and cisplatin before surgery to remove bladder cancer. It is for people who have the most common type of bladder cancer called transitional cell cancer.
If bladder cancer has grown into the muscle layer of the bladder, it is called invasive bladder cancer. We know from clinical trials that having chemotherapy before surgery to remove invasive bladder cancer can lower the risk of it coming back in the future.
Cisplatin is a chemotherapy drug doctors often use to treat bladder cancer. You usually have it at alongside another drug such as gemcitabine. In this trial, doctors are testing the combination of cisplatin and a drug called cabazitaxel.
The aims of the study are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 2 trial will recruit up to 30 people. Everybody taking part has cabazitaxel and cisplatin before having surgery to remove their bladder (a radical cystectomy).
You have both drugs through a drip into a vein once every 3 weeks. The day after your chemotherapy, you have an injection of a growth factor called G-CSF. This helps to reduce the risk of serious side effects. You have G-CSF as an injection under your skin (a subcutaneous injection).
Each 3 week period is called a cycle of treatment. You have 4 cycles of treatment, lasting about 3 months. You then have surgery.
The trial team will ask you to fill out some questionnaires before you start treatment, 3 times during chemotherapy and a few weeks after your last cycle of treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will also ask you to take part in 2 smaller studies. One is looking at whether an MRI scan can show if chemotherapy is working early in the treatment. If you agree to take part, you have 3 MRI scans - before you start treatment, after the 1st cycle of chemotherapy and after the 3rd cycle.
The other study is looking for cancer cells in your bloodstream. These are called circulating tumour cells or CTCs. Measuring CTCs may be a way for doctors to see whether or not treatment has worked. And it might help them work out the risk of the cancer coming back. If you agree to take part in this study, the researchers will take some extra blood samples before you start treatment, before each cycle of chemotherapy and before you have surgery.
Both of the smaller studies are optional. You don’t have to take part in either of them if you don’t want to. You can still take part in the trial.
You see the trial doctors and have some tests before you start treatment. The tests include
You go to hospital once every 3 weeks to have chemotherapy. This takes a few hours each time and you will probably need to stay in hospital overnight.
You may be able to give yourself the G-CSF injections at home - or a family member may be able to do it for you. If not, you either have these at the hospital or a district nurse will give them to you at home.
Before each cycle of chemotherapy, you have another hospital visit to see the trial team. At these visits, you have a physical examination and blood tests. You also fill out the quality of life questionnaires.
You have another CT scan and cystoscopy after 3 cycles of chemotherapy.
After your 4th cycle of treatment, you see the trial team once more. You then have your surgery within the next 6 weeks.
If you join the MRI study, there will be 3 extra hospital visits to have the scans.
The most common side effects of the chemotherapy drugs in this trial include
There is a risk of having an allergic reaction causing symptoms such as skin rash, itching, high temperature, shivering, redness of the face, dizziness, headache, breathlessness, anxiety and an urgent need to pass urine. The trial team will monitor you closely and treat any signs of a reaction.
We have more information about
Please note: You are advised not to drink grapefruit juice during the time you are having chemotherapy as part of this trial as it can interfere with the way the treatment works.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Amit Bahl
Sanofi
University Hospitals Bristol NHS Foundation Trust
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”