ESPAC-5F: European Study Group for Pancreatic Cancer - Trial 5F
Research type
Research Study
Full title
ESPAC-5F: European Study Group for Pancreatic Cancer - Trial 5F Four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy.
IRAS ID
139963
Contact name
Paula Ghaneh
Contact email
Eudract number
2013-003932-56
Research summary
Research Summary
Patients with borderline resectable pancreatic cancer (BR) have low resection rates and poor survival compared with patients who have clearly resectable (RS) tumours despite high quality surgery and adjuvant therapy. Meta-analyses have identified that these patients may benefit most from neoadjuvant therapy (before surgery) and should be the subject of a trial. Neoadjuvant therapy needs to be assessed in this group of patients to see if their outcomes can be improved.The aim of this study is to assess the feasibility and outcomes of comparing immediate surgery (Arm A) with either neoadjuvant gemcitabine plus capecitabine (GEMCAP) (Arm B), neoadjuvant oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX ) (Arm C) or neoadjuvant capecitabine based chemoradiotherapy (CRT) (Arm D) followed by surgery in patients with borderline resectable pancreatic cancer
Summary of Results
THE EUROPEAN STUDY GROUP FOR PANCREATIC CANCER - TRIAL 5F Four-arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy – ESPAC-5F.
The ESPAC-5 study was led by researchers at the University of Liverpool and recruited patients from hospitals around the UK and in Germany from September 2014 to December 2018. The study was funded by Cancer Research UK.
The ESPAC-5 F clinical trial recruited patients with pancreatic cancer that was growing very close to the major blood vessels near the pancreas. This is called borderline resectable (BR) pancreatic cancer. In borderline resectable cancer it may or may not be possible to remove the cancer, this depends on which blood vessels are affected and how far the cancer has grown. Patients with BR pancreatic cancer have a lower chance of having the cancer successfully removed and a lower survival chance compared with patient who have clearly resectable (RS) tumours.
The ESPAC-5F study looked at the feasibility of recruiting and treating patients with different types of chemotherapy and/or chemoradiotherapy before surgery (neoadjuvant therapy) to remove the cancer. The study collected data to investigate how patients respond to the treatment before surgery.
The aim of this study is to assess the feasibility and outcomes of comparing immediate surgery (Arm A) with either
• Neoadjuvant gemcitabine plus capecitabine (GEMCAP) (Arm B), Neoadjuvant oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX ) (Arm C)
• Neoadjuvant capecitabine based chemoradiotherapy (CRT) (Arm D)
The study recruited 90 patients onto the study The study showed no difference in the number of patients able to have g their cancer removed at the time of surgery, between those who had neoadjuvant therapy before surgery and those who went straight on to surgery.
The study showed there was a survival advantage at one year for those patient who had neoadjuvant therapy compared with immediate surgery.
Among the neoadjuvant treatments, FOLFIRINOX may show the best survival at one year versus immediate surgery.
The toxicity was higher in the FOLFIRINOX arm but overall this was manageable.
The overall conclusion of the study was that neoadjuvant therapy should be considered for patients with borderline resectable pancreatic cancer, but more studies are required to get more evidence.
To find out more about the study and the results please visit:
https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRBkWV8ufHnd8zPS7suowbUNQ7uX1aMKdtJm-2FJ5n6RGrD0QULl-2BR1DHQD77Gka3mZg-3D-3DEEQW_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJvbW9VqLgd7FOhTgBTSwSX8BTxf-2F8YPUpK35UyNLJ3dfubI-2FA776veXl84d4tKudbphs3eCJqh5V7X08h2qlGF-2FOPPmNvliLORuVqJ-2B47Tz56DTMAl44AOY0czs6JQXfB2X1fyEMWc9vDVJtheEOtKDNVLpHWOZTDdkgkJvsKbCQ-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Cd1d92c2d3db0491e200f08d9e59eee6a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637793293084282106%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=%2Flrh%2B0nKmBoMzy7qoNgVMF8Z%2FYbKGhK%2FvMcpRhqBkBo%3D&reserved=0
We would like to thank-you to all the study participants and their families for the amazing contribution they made to the piece of research.REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/0036
Date of REC Opinion
18 Mar 2014
REC opinion
Further Information Favourable Opinion