Imperial College London
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Professor Long R Jiao MD FRCS

Faculty of Medicine, Department of Surgery & Cancer

Professor of Surgery
 
 
 
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Contact

 

+44 (0)20 3313 3937l.jiao

 
 
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Location

 

BN1/15 Area BHammersmith HospitalHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Ghaneh:2020:10.1200/jco.2020.38.15_suppl.4505,
author = {Ghaneh, P and Palmer, DH and Cicconi, S and Halloran, C and Psarelli, EE and Rawcliffe, CL and Sripadam, R and Mukherjee, S and Wadsley, J and Al-Mukhtar, A and Jiao, LR and Wasan, HS and Carter, R and Graham, JS and Ammad, F and Evans, J and Tjaden, C and Hackert, T and Buchler, MW and Neoptolemos, JP},
doi = {10.1200/jco.2020.38.15_suppl.4505},
journal = {Journal of Clinical Oncology},
pages = {4505--4505},
title = {ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer.},
url = {http://dx.doi.org/10.1200/jco.2020.38.15_suppl.4505},
volume = {38},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - <jats:p> 4505 </jats:p><jats:p> Background: Patients with borderline resectable pancreatic cancer have poor survival and low resection rates. Neoadjuvant therapy may improve the outcome for these patients. The aim of this trial was to determine the feasibility and efficacy of a comparison of immediate surgery versus neoadjuvant GEMCAP or FOLFIRINOX or CRT. Methods: Eligible patients with NCCN defined borderline resectable (following central review of the baseline CT scan) and biopsy proven pancreatic cancer were randomised (stratified by centre) to receive immediate surgery, or neoadjuvant therapy of either 2 cycles of GEMCAP, or 4 cycles of FOLFIRINOX or 50.4Gy capecitabine-based CRT in 28 daily fractions over 5 ½ weeks. Patients were restaged at 4-6 weeks and underwent surgical exploration if still borderline resectable. Resected patients received adjuvant therapy. Follow up was 12 months. There was quality assurance of surgery and CRT. Primary endpoints were recruitment rate and resection rate (R1/R0). Secondary endpoints included overall survival and toxicity. A target of 90 patients was set to determine feasibility and resection rates. Rates will be presented as point estimates and survival compared across treatment arms using a log-rank test. Analyses will be on an ITT basis. Results: Between August 2014 and December 2018, 90 patients were randomised with 88 included in the full analysis set (32 immediate surgery, 20 GEMCAP, 20 FOLFIRINOX, 16 CRT). Median age was 63 years, 44% were men. WHO performance status was 0 and 1 in 45% and 55% respectively. Median CA19-9 was 603 kU/L at baseline. 44 (79%) patients completed neoadjuvant therapy. Recruitment rate was 21 patients per year. Resection rate was 62% for immediate surgery and 55% for neoadjuvant therapy (p=0.668). R0 resection rate on resected patients was 15% and 23% respectively (p=0.721). One year survival rate was 40% [95% CI, 26% – 62%] for immediate surgery and 77% [95%CI
AU  - Ghaneh,P
AU  - Palmer,DH
AU  - Cicconi,S
AU  - Halloran,C
AU  - Psarelli,EE
AU  - Rawcliffe,CL
AU  - Sripadam,R
AU  - Mukherjee,S
AU  - Wadsley,J
AU  - Al-Mukhtar,A
AU  - Jiao,LR
AU  - Wasan,HS
AU  - Carter,R
AU  - Graham,JS
AU  - Ammad,F
AU  - Evans,J
AU  - Tjaden,C
AU  - Hackert,T
AU  - Buchler,MW
AU  - Neoptolemos,JP
DO  - 10.1200/jco.2020.38.15_suppl.4505
EP  - 4505
PY  - 2020///
SN  - 0732-183X
SP  - 4505
TI  - ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer.
T2  - Journal of Clinical Oncology
UR  - http://dx.doi.org/10.1200/jco.2020.38.15_suppl.4505
VL  - 38
ER  -
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