Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer (NCT04460352)
NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: McGill University Health Centre — Montreal, Quebec
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- McGill University Health Centre — Montreal, Quebec
- Cancer Clinical Trials Unit (CCTU) at St. James's Hospital — Dublin, Dublin
- Oslo universitetssykehus — Oslo,
- Universitetssykehuset Nord-Norge — Tromsø,
- St Olavs Hospital — Trondheim,
- Linköpings universitetssjukhus — Linköping,
- Skånes universitetssjukhus — Lund,
- Örebro universitetssjukhus — Örebro,
- Karolinska University Hospital — Stockholm,
- Norrlands universitetssjukhus — Umeå,
- Akademiska sjukhuset — Uppsala,
- Chang Gung Memorial Hospital — Linkou District,
📞 Contact the Study Coordinator
Phone: +46-707-375186
Email: magnus.nilsson@ki.se
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Esophageal Squamous Cell Carcinoma
- A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy — Fort Myers, Florida
- Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC — Atlanta, Georgia
- Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) — Pittsburgh, Pennsylvania
- A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B) — Tucson, Arizona
- A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types — Denver, Colorado
Explore by condition: All Esophageal Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.