An interventional study of Active surveillance in Esophageal Cancer, Active Surveillance and Neoadjuvant Chemoradiotherapy, sponsored by Erasmus Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
An active surveillance approach is proposed 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 aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.
Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Active surveillance
Procedure: Active surveillance
Patients enrolled in the active surveillance arm will undergo diagnostic evaluations every 3 months in the first year after completion of neoadjuvant treatment, every 4 months in the second year, every 6 months in the third year and yearly in the 4th and 5th year of follow up, or when symptoms or results of any diagnostic test require shorter assessment intervals. In the active surveillance arm, surgical resection will be offered only to those patients, in whom a locoregional regrowth is highly suspected or proven, without any signs of distant dissemination.
Overall survival
Time frame: the interval between the moment of achieving cCR (i.e. the moment the patient will start the intervention) and death or last follow-up, with a minimal follow-up of two years after reaching cCR.
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Plan to share: Undecided
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center