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.
Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.
Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
Performance status ECOG 0-1.
Adequate organ function.
M1 according to current (8th) version of of the AJCC TNM classification.
cT4b according to current (8th) version of of the AJCC TNM classification.
Primary tumor not resectable without laryngectomy.
Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.
Karolinska University Hospital
Lead sponsor
University of Leipzig
Collaborator
The Swedish Research Council
Collaborator