NHS trial to improve outcomes for bladder cancer patients launches across the UK

Posted 14th January 2015

The Clatterbridge Cancer Centre is leading the national trial, which is being run through Liverpool Clinical Trials Unit.

A phase-two placebo-controlled randomised trial of a drug which could improve the outcome of patients with bladder cancer has been approved. The trial, which will be led by The Clatterbridge Cancer Centre and Liverpool Clinical Trials Unit, is taking place at 15 cancer centres across England, Scotland and Wales*.

Nintedanib is a form of oral chemotherapy, which has been shown to have a potential role in shrinking bladder cancer tumours. Nintedanib will be tested in a randomised trial in combination with standard chemotherapy for patients with muscle-invasive bladder cancer which is confined to the bladder itself, to see whether the addition of nintedanib can significantly increase the chances of improved outcomes for patients.

Dr Syed Hussain, Consultant Medical Oncologist at The Clatterbridge Cancer Centre and Clinical Senior Lecturer at the University of Liverpool, is the chief investigator of this study. Dr Hussain commented: “Currently, one-third of bladder cancer patients show a complete pathological response to treatment after initial chemotherapy, meaning all cancer cells are removed and, even under a microscope, no sign of the cancer remains. Our research investigates whether the addition of the drug nintedanib with standard chemotherapy improves this response rate to over 50 per cent, which will be a fantastic outcome.

“Bladder cancer patients would usually receive chemotherapy to shrink the cancer tumour, followed by surgery or radiotherapy to remove the remaining cells. The new drug will be administered before radical surgery or radical chemoradiotherapy, depending on the treatment plan, to offer patients a stronger chance of all cancer cells being removed, meaning there is a much slimmer chance of cancer coming back in the bladder or in any other parts of the body.”

Michael Harrison, 67, from Old Swan, was diagnosed with bladder cancer in August 2014 after visiting his doctor with blood in his urine. Michael was referred to The Clatterbridge Cancer Centre where Dr Syed Hussain offered him the chance to take part in the brand new trial.

Michael, said; “Dr Hussain was fantastic in explaining all of the treatment options available to me. I opted for the trial as I didn’t feel I had anything to lose and wanted to give myself the best shot. There are four stages to the initial part of the trial which involve chemotherapy coupled with oral drugs, and I’ve recently finished all of these.

“Apart from minor side effects I’ve felt ok and the nurses at The Clatterbridge Cancer Centre even managed to get around my fear of needles by inserting a PICC line (peripherally inserted central catheter) in my arm, which has been a god send.

“I’ll be having surgery after Christmas and I’m trying to stay positive that everything will be a success. I can’t thank the doctors and nurses at Clatterbridge enough for the support they’ve given me – they’re always so friendly and have managed to put me at ease along the way.”

The trial is expected to run for up to two years nationwide, before The Clatterbridge Cancer Centre and Liverpool Clinical Trials Unit analyse the success rates of all patients involved. If the phase II trial confirms improved outcome with the addition of nintedanib as compared to placebo in combination with standard chemotherapy, the patient cohort will be expanded within a randomised phase III trial.

About bladder cancer

There are 10,000 new cases of bladder cancer recorded every year in the UK, but one promising statistic is that eight out of ten patients are diagnosed with early stage cancer. This highlights the importance of understanding what to look out for as the earlier any cancer is diagnosed, the better the outlook for the patient.

The most common symptom of bladder cancer is blood in the urine; this can happen suddenly and may come and go. Other symptoms can include a burning sensation when passing urine, or the need to use the toilet more often and although all these symptoms can mean various other things, such as infections and kidney problems, it’s important for patients to get themselves checked out by their GP to ensure early diagnosis.

Research has shown that smoking is the biggest cause of bladder cancer, with one in three cases attributed to the chemicals found in cigarettes. Chemicals that are inhaled through smoking are filtered by the kidneys and can end up in the urine, which damages cells in the bladder and over a long period of time, can cause cancer. Age is also an important factor, with most cases presenting themselves in adults over 50.

For more information on other clinical trials available, please visit www.clatterbridgecc.nhs.uk