PRICKLE
Research type
Research Study
Full title
Pancreatic Resectability in Cancers with Known Limited Extension (PRICKLE) - A single-centre phase 2a study of Gemcitabine plus Nab-paclitaxel for borderline unresectable locally advanced pancreatic cancer.
IRAS ID
132700
Contact name
Bristi Basu
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2013-004200-19
Research summary
Pancreatic Ductal Adenocarcinoma is a disease with a very poor prognosis, for which there is a great need for new treatment options. Borderline unresectable Locally Advanced Pancreatic Cancer (LAPC) accounts for 30-40% of advanced disease, and is not amenable to surgical resection. It shares a poor prognosis with a median survival of around 9 months. Treatment prior to surgery might be beneficial in this group of patients and therefore there is interest in pursuing new treatment strategies in this setting.
The recently reported Metastatic Pancreatic Adenocarcinoma Clinical Trial study suggests impressive efficacy of the combination of Gemcitabine (GEM) plus nab-paclitaxel (Abraxane, ABX) in stage IV pancreatic cancer patients. The tumour response seen in these patients as a result of GEM & ABX may translate to a realistic prospect of downstaging LAPC tumours sufficiently to enable resection. Even moderate tumour shrinkage might be sufficient to separate the tumour from major vessels and render it operable. Such an outcome may significantly alter the poor survival outcomes in this group of patients.
This is an single-centre, non-randomised, phase 2a, single arm, Simon two-stage design trial of ABX & GEM in patients with histological documentation of pancreatic ductal adenocarcinoma who are determined by central radiological review to have “category 2” borderline unresectable LAPC. We will investigate the feasibility of administering ABX & GEM in terms of safety and efficacy, and will study activity both in terms of radiological response and the feasibility of downstaging patients to “category 1” status, in order to attempt resection after up to 6 cycles of treatment. In addition to adding to data on the safety and tolerability of this combination, peri- and post-operative morbidity following this treatment will be evaluated. As part of the study, detailed correlative studies will be undertaken to evaluate the mechanism of action of the combination, at a tissue level, a circulating biomarker level and a radiological level.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/0146
Date of REC Opinion
13 Jun 2014
REC opinion
Further Information Favourable Opinion