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
abstract
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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.
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type of project
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clinical studies
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status
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ongoing - recruiting phase
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start of project
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2017
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end of project
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2024
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study design
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Phase II - III
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responsible person
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PD Dr. med. Thomas Ruhstaller
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