PRICKLE follow up
Research type
Research Study
Full title
Observational study of long term outcomes of patients consented to PRICKLE
IRAS ID
166105
Contact name
Bristi Basu
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
3 years, 0 months, 8 days
Research summary
Research Summary
In the absence of resectability, pancreatic ductal adenocarcinoma (PDAC) is almost uniformly lethal; therefore there is a great need to optimize novel therapeutic approaches. Only around 10-20% of patients present with operable disease and with addition of adjuvant chemotherapy, 5-yr survival in this group is 29%.
The Cambridge University Hospitals NHS Foundation Trust and University of Cambridge investigator-initiated PRICKLE interventional trial (entitled “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) was set up as a single-centre, non-randomised, phase 2a, single arm, trial of nab-paclitaxel + gemcitabine in patients with histological documentation of PDAC who were determined by central radiological review to have borderline unresectable locally advanced pancreatic cancer. The aim of the PRICKLE study was to evaluate safety and efficacy, and activity both in terms of radiological response and the feasibility of downstaging patients in order to attempt resection after up to 6 cycles of treatment. The hypothesis was that if patients can be downstaged sufficiently, and rendered resectable, this may impact long-term outcomes of PDAC patients with an otherwise poor prognosis.
This is a single-centre survival follow-up study of patients who consented to the PRICKLE study. In order to assess the long-term effect of the PRICKLE study, we aim to collect data approximately every 3 months on the participant’s survival status, disease recurrence and subsequent treatments until the participant’s death.
All participants who gave written informed consent to the PRICKLE study will be approached to participate in this study. We will include participants who were AND were not deemed eligible for PRICKLE drug treatment. This will enable us to evaluate factors that may influence outcome patterns in similar groups of pancreatic cancer patients. No visits or procedures are required for this study.
Summary of Results
This study reflects the long-term outcome data on patients recruited to the PRICKLE study with median follow-up of 66.2 months. Patients with borderline (un)resectable pancreatic adenocarcinoma, treated with gemcitabine + nab-paclitaxel had median overall survival of 30.62 months; progression-free survival of 16.20 months and for patients who were rendered resectable (n=7 (78%)) median recurrence free survival from surgery of 17.48 months.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0284
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion