Overview

A Study of Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Cancer of the Esophagus

Status:
Recruiting

Trial end date:
2031-12-31

Target enrollment:

Participant gender:

Summary

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy with regard to the main secondary endpoint global health related quality of life (HRQOL) 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.

Phase:

Phase 3

Details

Lead Sponsor:

Karolinska University Hospital

Collaborators:

The Swedish Research Council
University of Leipzig

Treatments:

Albumin-Bound Paclitaxel
Calcium
Carboplatin
Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin
Paclitaxel