BBC
Research type
Research Study
Full title
Phase II study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront surgery in patients with resectable proximal biliary tract cancer:
IRAS ID
138743
Contact name
Gemma Nanson
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2014-002382-30
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Research Summary
Biliary Tract cancer is a relatively rare cancer with a very poor prognosis. Surgery offers the only chance of cure but unfortunately unfortunately, many patients experience disease recurrence after surgery. For other types of tumour, chemotherapy is often given before surgery (neoadjuvant therapy) in order to destroy microscopic tumour deposits that may not be removed by surgery, reducing the chance of post-operative disease recurrence. However, this approach has not been trialed in biliary tract cancer. This is therefore the first trial to investigate treating patients with bile duct cancer with chemotherapy (cisplatin and gemcitabine) before surgery in order to improve overall survival by reducing the chances of recurrence after surgery.
Summary of Results
the Study Was abandon before recruiting any patients. This was due to due to changes in standard of care and financial shortfalls. NOTE: Trial never opened to recruitment and no patients were randomised
Change in Standard of Care: A national shift in the Standard of Care and patient management of patient with biliary tract cancers. With the increasing role of immunotherapy for many cancer types, a recent global phase III randomised trial has established the combination of chemotherapy with immunotherapy as the new standard of care for systemic therapy for advanced biliary tract cancer. Thus, in order to retain the relevance of the BBC trial, a significant re-design to incorporate immunotherapy is required.
Shortfalls in the funding required to deliver the project. The project was original costed as small pilot study but as the protocol and set-up of the project has progressed it has become clear the grant will not sufficient to deliver the requirements of a CTIMP with significant patient follow-up.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0021
Date of REC Opinion
23 Feb 2015
REC opinion
Further Information Favourable Opinion