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

Study acronym: NEEDS
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 11 to 12
    • Primary completion date: Sep 18, 2026 to Dec 31, 2026
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary endpoints: 1 to 3
    • Enrollment target: 1200 to 1020
    • Study sites: 9 to 11
    • Secondary endpoints: 13 to 12
    v4
  4. Study sites: 2 to 9
    • Study title shortened, about 5 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 1000 to 1200
    • Study sites: 1 to 2
    • Start date changed from estimate of Sep 18, 2020 to Nov 27, 2020
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04460352
Lead Sponsor Karolinska University Hospital
Collaborators: University of Leipzig, The Swedish Research Council
Conditions
(from sponsor)		 Esophageal Squamous Cell Carcinoma
Related terms Esophageal Squamous Cell Carcinoma
Enrollment 1,020 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov