Esophageal Cancer Clinical Trial
Official title:
Accuracy of Detecting Residual Disease After Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: the preSINO Trial (Pre-Surgery If Needed for Oesophageal Cancer)
Prospective, multi-centre, diagnostic cohort study investigating the accuracy of positron emission tomography with computed tomography (PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) for detecting residual disease after neoadjuvant chemoradiotherapy in patients with potentially curable esophageal squamous cell carcinoma (SCC).
After neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, high pathologically
complete response (pCR) rates are being achieved in patients with squamous cell carcinoma
(SCC). An active surveillance strategy has been proposed for SCC patients with clinically
complete response (cCR) after nCRT. To justify omitting surgical resection, patients with
residual disease should be accurately identified.
The objective of this study is to assess the accuracy of response evaluations after nCRT
based on the preSANO trial, including positron emission tomography with computed tomography
(PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with
fine-needle aspiration (FNA) in patients with potentially curable esophageal SCC.
Operable esophageal SCC patients who are planned to undergo nCRT according to the CROSS
regimen and are planned to undergo surgery will be recruited from four Asian centers. Four to
six weeks after completion of nCRT, patients will undergo a first clinical response
evaluation (CRE-1) consisting of endoscopic bite-on-bite biopsies. In patients without
histological evidence of residual tumor (i.e. without positive biopsies), surgery will be
postponed another six weeks. A second clinical response evaluation (CRE-2) will be performed
10-12 weeks after completion of nCRT, consisting of PET-CT, endoscopic bite-on-bite biopsies
and EUS with FNA. Immediately after CRE-2 all patients without evidence of distant metastases
will undergo esophagectomy. Results of CRE-1 and CRE-2 as well as results of single
diagnostic modalities will be correlated to pathological response in the resection specimen
for calculation of sensitivity, specificity, negative predictive value and positive
predictive value.
If the current study shows that major residual disease (>10% residual carcinoma at the
primary tumor site and any residual nodal disease) can be accurately (i.e. with sensitivity
of 80.5%) detected in patients with esophageal SCC, a prospective trial will be conducted
comparing active surveillance with standard esophagectomy in patients with a clinically
complete response after nCRT (SINO trial).
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