Project

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

Automatically Closed ยท 2017 until 2024

Type
Clinical Studies
Range
Multicentric, KSSG as main centre
Units
Status
Automatically Closed
Start Date
2017
End Date
2024
Financing
SAKK
Study Design
Phase II - III
Brief description/objective

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.