NEO-BLADE Version: 2
Research type
Research Study
Full title
Phase II randomised placebo controlled NEOadjuvant chemotherapy study of Nintedanib with Gemcitabine and Cisplatin in locally advanced muscle invasive BLADder cancEr
IRAS ID
105317
Contact name
Syed Hussain
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2012-004895-21
Duration of Study in the UK
7 years, 3 months, 31 days
Research summary
Of all the cancers affecting the organs involved with reproduction, urine production and excretion, bladder cancer is the second most common. Almost 25% of patients have bladder cancer that has invaded the muscle at the time of diagnosis.
Typically, patients with muscle-invasive bladder cancer will undergo two phases of treatment. The first phase for all patients consists of treatment with two different drugs together (Gemcitabine and Cisplatin) and is known as neo-adjuvant combination chemotherapy.Neo-adjuvant chemotherapy of Gemcitabine and Cisplatin for patients with muscle-invasive bladder cancer is used for two key reasons. Firstly, it has been shown to improve the survival of patients who have micro metastases (disease that has spread to other parts of the body but is so small that it cannot be detected). Secondly, neo-adjuvant treatment aims to shrink the tumour in the bladder so that surgery for removal of the bladder can be prevented.
Nintedanib is a new chemotherapy drug which is thought to be beneficial for slowing down the growth of cancerous tumours, and therefore may be beneficial as a treatment for muscle-invasive bladder cancer.
The second phase of treatment, after neoadjuvant chemotherapy, is known as ‘radical’ treatment and has the intention of curing the patient’s cancer. For patients with muscle-invasive bladder cancer the radical treatment options are removal of the bladder (surgery), further chemotherapy or a combination of chemotherapy and radiotherapy. The type of radical treatment is selected by the patient and their doctor depending on what is best for the patient.
In this study, we will investigate a new combination of neo-adjuvant chemotherapy in the first phase of treatment for 120 patients with muscle-invasive bladder cancer. This new combination involves adding the new chemotherapy drug Nintedanib to the usual combination of Gemcitabine and Cisplatin. A small, sub-study will be carried out alongside the main study for renally impaired patients to confirm the maximum tolerated dose of Nintedanib added to a standard dose of cisplatin (split dose) and gemcitabine in these patients with bladder cancer.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0134
Date of REC Opinion
23 Apr 2013
REC opinion
Further Information Favourable Opinion