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BBC: Phase II study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront Surgery in patients with resectable proximal biliary tract cancer

BBC-01

BBC: Phase II study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront Surgery in patients with resectable proximal biliary tract cancer
Funding North West Surgical Trials Centre and BASO
Portfolio Cancer
Interventions Medicine,Surgery
Randomised Yes
Status Funding awarded/in set-up
Start Date 01-Jan-0001

Bile duct cancer is a relatively reare cancer with a very poor diagnosis. Surgery offers the only chance of a cure, but unfortunately only a small number of patients are offered Surgery because the disease is often advanced when it is discovered. For other types of tumour, advanced disease can be treated with chemotherapy to shrink the tumour allowing curative Surgery. However, this has never been tried in bile duct cancer. This is the first ever trial to investigate treating patients with locally advanced bile duct cancer with the best available chemotherapy to try and shrink their tumours and allow Surgery. as the chemotherapy used in bile duct cancer has not previously been given before Surgery, the main aim of the study will check that this approach is safe and Surgery can still be performed without increased complications. as well as assessing safety, the study will also look at how different tumours respond. Samples of tumour are taken during a routine camera test to confirm the diagnosis of bile duct cancer and as part of this study researchers will be able to compare tumour taken during this camera test (before treatment) and tumours removed at Surgery (after treatment) to try and identify why some tumours repsond differently. At the same time, blood tests will be taken as patients are treated with chemotherapy to try and identify molecules that let doctors assess how well the treatment is working