Abstract
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. 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
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Heijl, Mark van;
[1]
Gaast, Ate van der;
[2]
Nieuwenhuijzen, Grard AP;
[3]
Bonenkamp, Han J;
[4]
Plukker, John ThM;
[5]
Bilgen, Ernst J Spillenaar;
[6]
Kate, Fibo JW ten;
[7]
Boellaard, Ronald;
[8]
Pruim, Jan;
[9]
Sloof, Gerrit W;
[10]
Lanschot, J Jan B van [Department of Surgery, Academic Medical Center, Amsterdam (Netherlands);
Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)];
Omloo, Jikke MT;
Berge Henegouwen, Mark I van;
Busch, Olivier RC;
[1]
Tilanus, Hugo W;
[11]
Bossuyt, Patrick MM;
[12]
Hoekstra, Otto S;
[13]
Stoker, Jaap;
[14]
Hulshof, Maarten CCM
[15]
- Department of Surgery, Academic Medical Center, Amsterdam (Netherlands)
- Department of Medical Oncology, Erasmus Medical Center, Rotterdam (Netherlands)
- Department of Surgery, Catharina Hospital Eindhoven, Eindhoven (Netherlands)
- Department of Surgery, Radboud University Medical Center, Nijmegen (Netherlands)
- Department of Surgery, University Medical Center Groningen, Groningen (Netherlands)
- Department of Surgery, Rijnstate Hospital, Arnhem (Netherlands)
- Department of Pathology, Academic Medical Center, Amsterdam (Netherlands)
- Department of Nuclear Medicine and PET research, VU Medical Center, Amsterdam (Netherlands)
- Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Groningen (Netherlands)
- Department of Nuclear Medicine, Academic Medical Center, Amsterdam (Netherlands)
- Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)
- Department of Clinical Epidiomiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam (Netherlands)
- Department of Nuclear Medicine, VU Medical Center, Amsterdam (Netherlands)
- Department of Radiology, Academic Medical Center, Amsterdam (Netherlands)
- Department of Radiotherapy, Academic Medical Center, Amsterdam (Netherlands)
Citation Formats
Heijl, Mark van, Gaast, Ate van der, Nieuwenhuijzen, Grard AP, Bonenkamp, Han J, Plukker, John ThM, Bilgen, Ernst J Spillenaar, Kate, Fibo JW ten, Boellaard, Ronald, Pruim, Jan, Sloof, Gerrit W, Lanschot, J Jan B van [Department of Surgery, Academic Medical Center, Amsterdam (Netherlands), Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)], Omloo, Jikke MT, Berge Henegouwen, Mark I van, Busch, Olivier RC, Tilanus, Hugo W, Bossuyt, Patrick MM, Hoekstra, Otto S, Stoker, Jaap, and Hulshof, Maarten CCM.
NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial).
United Kingdom: N. p.,
2008.
Web.
doi:10.1186/1756-6649-8-3.
Heijl, Mark van, Gaast, Ate van der, Nieuwenhuijzen, Grard AP, Bonenkamp, Han J, Plukker, John ThM, Bilgen, Ernst J Spillenaar, Kate, Fibo JW ten, Boellaard, Ronald, Pruim, Jan, Sloof, Gerrit W, Lanschot, J Jan B van [Department of Surgery, Academic Medical Center, Amsterdam (Netherlands), Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)], Omloo, Jikke MT, Berge Henegouwen, Mark I van, Busch, Olivier RC, Tilanus, Hugo W, Bossuyt, Patrick MM, Hoekstra, Otto S, Stoker, Jaap, & Hulshof, Maarten CCM.
NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial).
United Kingdom.
https://doi.org/10.1186/1756-6649-8-3
Heijl, Mark van, Gaast, Ate van der, Nieuwenhuijzen, Grard AP, Bonenkamp, Han J, Plukker, John ThM, Bilgen, Ernst J Spillenaar, Kate, Fibo JW ten, Boellaard, Ronald, Pruim, Jan, Sloof, Gerrit W, Lanschot, J Jan B van [Department of Surgery, Academic Medical Center, Amsterdam (Netherlands), Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)], Omloo, Jikke MT, Berge Henegouwen, Mark I van, Busch, Olivier RC, Tilanus, Hugo W, Bossuyt, Patrick MM, Hoekstra, Otto S, Stoker, Jaap, and Hulshof, Maarten CCM.
2008.
"NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial)."
United Kingdom.
https://doi.org/10.1186/1756-6649-8-3.
@misc{etde_22387018,
title = {NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial)}
author = {Heijl, Mark van, Gaast, Ate van der, Nieuwenhuijzen, Grard AP, Bonenkamp, Han J, Plukker, John ThM, Bilgen, Ernst J Spillenaar, Kate, Fibo JW ten, Boellaard, Ronald, Pruim, Jan, Sloof, Gerrit W, Lanschot, J Jan B van [Department of Surgery, Academic Medical Center, Amsterdam (Netherlands), Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)], Omloo, Jikke MT, Berge Henegouwen, Mark I van, Busch, Olivier RC, Tilanus, Hugo W, Bossuyt, Patrick MM, Hoekstra, Otto S, Stoker, Jaap, and Hulshof, Maarten CCM}
abstractNote = {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. 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). 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. ISRCTN45750457.}
doi = {10.1186/1756-6649-8-3}
journal = []
volume = {8}
journal type = {AC}
place = {United Kingdom}
year = {2008}
month = {Jul}
}
title = {NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial)}
author = {Heijl, Mark van, Gaast, Ate van der, Nieuwenhuijzen, Grard AP, Bonenkamp, Han J, Plukker, John ThM, Bilgen, Ernst J Spillenaar, Kate, Fibo JW ten, Boellaard, Ronald, Pruim, Jan, Sloof, Gerrit W, Lanschot, J Jan B van [Department of Surgery, Academic Medical Center, Amsterdam (Netherlands), Department of Surgery, Erasmus Medical Center, Rotterdam (Netherlands)], Omloo, Jikke MT, Berge Henegouwen, Mark I van, Busch, Olivier RC, Tilanus, Hugo W, Bossuyt, Patrick MM, Hoekstra, Otto S, Stoker, Jaap, and Hulshof, Maarten CCM}
abstractNote = {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. 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). 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. ISRCTN45750457.}
doi = {10.1186/1756-6649-8-3}
journal = []
volume = {8}
journal type = {AC}
place = {United Kingdom}
year = {2008}
month = {Jul}
}