NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial).
BACKGROUND
Surgical resection is the preferred treatment of potentially curable esophageal cancer. To improve long term patient outcome, many institutes apply neoadjuvant chemoradiotherapy. In a large proportion of patients no response to chemoradiotherapy is achieved. These patients suffer from toxic and ineffective neoadjuvant treatment, while appropriate surgical therapy is delayed. For this reason a diagnostic test that allows for accurate prediction of tumor response early during chemoradiotherapy is of crucial importance. CT-scan and endoscopic ultrasound have limited accuracy in predicting histopathologic tumor response. Data suggest that metabolic changes in tumor tissue as measured by FDG-PET predict response better. This study aims to compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable esophageal cancer.


METHODS
Prognostic accuracy study, embedded in a randomized multicenter Dutch trial comparing neoadjuvant chemoradiotherapy for 5 weeks followed by surgery versus surgery alone for esophageal cancer. This prognostic accuracy study is performed only in the neoadjuvant arm of the randomized trial. In 6 centers, 150 consecutive patients will be included over a 3 year period. FDG-PET and CT-scan will be performed before and 2 weeks after the start of the chemoradiotherapy. All patients complete the 5 weeks regimen of neoadjuvant chemoradiotherapy, regardless the test results. Pathological examination of the surgical resection specimen will be used as reference standard. Responders are defined as patients with < 10% viable residual tumor cells (Mandard-score).Difference in accuracy (area under ROC curve) and negative predictive value between FDG-PET and CT-scan are primary endpoints. Furthermore, an economic evaluation will be performed, comparing survival and costs associated with the use of FDG-PET (or CT-scan) to predict tumor response with survival and costs of neoadjuvant chemoradiotherapy without prediction of response (reference strategy).


CONCLUSIONS
The NEOPEC-trial could be the first sufficiently powered study that helps justify implementation of FDG-PET for response-monitoring in patients with esophageal cancer in clinical practice.


BACKGROUND
ISRCTN45750457.
van Heijl
Mark
M
Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands. m.vanheijl@amc.uva.nl
Omloo
Jikke M T
JM
van Berge Henegouwen
Mark I
MI
Busch
Olivier R C
OR
Tilanus
Hugo W
HW
Bossuyt
Patrick M M
PM
Hoekstra
Otto S
OS
Stoker
Jaap
J
Hulshof
Maarten C C M
MC
van der Gaast
Ate
A
Nieuwenhuijzen
Grard A P
GA
Bonenkamp
Han J
HJ
Plukker
John Th M
JT
Bilgen
Ernst J Spillenaar
EJ
Ten Kate
Fibo J W
FJ
Boellaard
Ronald
R
Pruim
Jan
J
Sloof
Gerrit W
GW
van Lanschot
J Jan B
JJ