NCT04460352: NEEDS

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

Recruiting now Phase 3 Last updated 6 March 2025

What this trial tests

Phase 3 trial testing Neoadjuvant radiotherapy (arm A) in Esophageal Squamous Cell Carcinoma in 1,020 participants. Currently enrolling.

Timeline

27 November 2020

Primary endpoint
31 December 2026

31 December 2031

Quick facts

Lead sponsor	Karolinska University Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,020
Start date	27 November 2020
Primary completion	31 December 2026
Estimated completion	31 December 2031
Sites	12 locations across Sweden, Taiwan, Ireland, Norway, Canada

Drugs / interventions tested

• Neoadjuvant radiotherapy (arm A)
• Carboplatin, paclitaxel
• Esophagectomy
• Neoadjuvant radiotherapy (arm B)
• Carboplatin, paclitaxel
• Cisplatin, paclitaxel — full drug profile →
• Oxaliplatin, calcium folinate, 5-fluorouracil — full drug profile →
• Esophagectomy

Conditions studied

• Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →

Sponsor

Karolinska University Hospital

Who can join

Adults 18 to 80, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current status and perspectives of esophageal cancer: a comprehensive review.
   Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645
2. Neoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trial.
   Nilsson M, Olafsdottir H, Alexandersson von Döbeln G, Villegas F, et al · · 2022 · cited 25× · PMID 35912196 · DOI 10.3389/fonc.2022.917961
3. Tolerability, toxicity, and outcomes following surgical and non-surgical approaches to the management of patients with locally advanced oesophageal squamous cell carcinoma: multicentre retrospective cohort study.
   RadioRoux Collaborative . · · 2025 · PMID 40920998 · DOI 10.1093/bjsopen/zraf078