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

Recruiting Phase 3 Interventional Study
Esophageal Squamous Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,020 (estimated)
Sponsor
Karolinska University Hospital · Other
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About This Trial
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 eatin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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…
Contacts

Magnus Nilsson, MD, PhD

+46-707-375186

magnus.nilsson@ki.se

CONTACT

Mats Hellström

mats.hellstrom@regionstockholm.se

CONTACT