Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer

We propose an active surveillance approach after completion of neoadjuvant
chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e.
Surgery As Needed for Oesophageal cancer) approach, surgical resection is
offered only to patients in whom a locoregional regrowth is highly suspected or
proven, without distant dissemination. Such an organ-preserving strategy can
have great advantages, but is only justified if long-term survival is
non-inferior to that of the current standard trimodality approach comprising
neoadjuvant chemoradiotherapy followed by standard surgery

The main objective is to compare overall survival of an active surveillance
approach to that of standard surgery for patients with either squamous cell- or
adenocarcinoma of the oesophagus or oesophago-gastric junction

Phase III multi-centre, stepped-wedge cluster randomised controlled trial

An active surveillance approach after completion of nCRT for carcinoma of the
oesophagus. In this SANO (i.e. Surgery As
Needed for Oesophageal cancer) approach, patients undergo active surveillance
after completion of nCRT. Surgical resection
is offered only to patients in whom a residual/recurrent disease is highly
suspected or histologically proven, without distant
dissemination.

The main burden for participating patients are the additional diagnostic tests
as part of the CREs and surveillance evaluations after completion of nCRT. The
number and frequency of diagnostic rounds depend on whether residual disease is
detected. The CREs and surveillance evaluations consist of PET-CT, endoscopy
and endoscopic ultrasonography (EUS) with or without fine needle aspiration
(FNA). All three tests carry a minimal risk of complications. The main risk for
patients in the active surveillance arm is that tumour regrowth is detected
beyond the resectability limit, that distant metastases develop from local
regrowths and that delayed surgery is potentially associated with an increase
in postoperative morbidity. Therefore, an intensive surveillance regimen has
been incorporated and strict stopping rules for ensuring patients oncological
safety have been formulated for this trial. Participating patients may benefit
by the avoidance of an oesophagectomy, which is associated with severe
morbidity, substantial postoperative mortality and impact on patients* quality
of life. Moreover, it is expected that ultimately health care costs will
substantially decrease by active surveillance.