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Study identifier: NCT04460352 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingNEEDS

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

Condition: Esophageal Squamous Cell Carcinoma  ·  Sponsor: Karolinska University Hospital

PhasePhase 3
Planned participants1020
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where12 locations · 5 countries

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Magnus Nilsson, MD, PhD  ·  +46-707-375186  ·  magnus.nilsson@ki.se

Mats Hellström  ·  mats.hellstrom@regionstockholm.se

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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 board. * Performance status ECOG 0-1. * Adequate organ function. * Women of childbearing potential (WOCBP\*) must have a negative serum or urine pregnancy test. * Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment. * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * Before patient registration/randomization, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations. Exclusion Criteria: * M1 according to current (8th) version of of the AJCC TNM classification. * cT4b according to current (8th) version of of the AJCC TNM classification. * Primary tumor not resectable without laryngectomy. * Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy. * Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy. * Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry. * Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields. * Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens. * Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder. (Criteria slightly shortened)

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (12)

McGill University Health CentreMontreal, Quebec, CanadaRecruiting
Cancer Clinical Trials Unit (CCTU) at St. James's HospitalDublin, Dublin, IrelandRecruiting
Oslo universitetssykehusOslo, NorwayRecruiting
Universitetssykehuset Nord-NorgeTromsø, NorwayRecruiting
St Olavs HospitalTrondheim, NorwayRecruiting
Linköpings universitetssjukhusLinköping, SwedenRecruiting
Skånes universitetssjukhusLund, SwedenRecruiting
Örebro universitetssjukhusÖrebro, SwedenRecruiting
Karolinska University HospitalStockholm, SwedenRecruiting
Norrlands universitetssjukhusUmeå, SwedenRecruiting
Akademiska sjukhusetUppsala, SwedenRecruiting
Chang Gung Memorial HospitalLinkou District, TaiwanRecruiting

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

MontrealDublinOsloTromsø

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