Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation. The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.

NCT Number	NCT04460352
Lead Sponsor	Karolinska University Hospital Collaborators: University of Leipzig, The Swedish Research Council
Conditions	Esophageal Squamous Cell Carcinoma
Enrollment	1,020 participants
Start Date	2020-11-27
Primary Completion	2026-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-06