Kantonsspital St.Gallen
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SAKK PRODIGE 32: Systematic surgery vs monitoring and salvage surgery in opera-ble oesophageal cancer in complete clinical response after chemoradiation Strategic multicenter randomized phase II- III trial

Thomas Ruhstaller

abstract Patients with locally advanced oesophageal cancer are evaluable for a participation in this trial. The standard treatment for these patients is neoadjuvant chemoradia-tion followed by surgery. Patients receiving a complete pathological remission after neoadjuvant therapy have a 5y-survival of 75-80% (Swiss data), patients with macro-scopic tumor left do much worse with a 5y survival rate of only about 40%. The direct oesophagectomy is the international standard however, it has itself a relevant long-term morbidity and a mortality of 5-10%. Therefore, it exists a chronic controversy whether patients with good response after neoadjuvant therapy should still be operated or not, assuming this operation is without rele-vant impact on survival but increases the morbidity and mortality only.
   
type of project clinical studies
status ongoing - recruiting phase
start of project 2017
end of project 2024
study design Phase II - III
responsible person PD Dr. med. Thomas Ruhstaller