A Study of Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Cancer of the Esophagus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Esophageal Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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 randomisationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04460352
- Collaborators
- University of Leipzig
- The Swedish Research Council
- Investigators
- Study Chair: Magnus Nilsson, MD, PhD Karolinska University Hospital Study Chair: Florian Lordick, MD, PhD Leipzig University Medical Center
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