NCT04460352

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

NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Neoadjuvant radiotherapy (arm A)	1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.
DRUG	Carboplatin, paclitaxel	Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy
PROCEDURE	Esophagectomy	Esophagectomy performed within 8 weeks after termination of chemoradiotherapy
RADIATION	Neoadjuvant radiotherapy (arm B)	Two alternative schemes: 1. 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy. 2. 2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy.
DRUG	Carboplatin, paclitaxel	Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy (5 weeks or 6 weeks, depending on the radiotherapy regimen used).
DRUG	Cisplatin, paclitaxel	Cisplatin 75mg/m2 on the first day of weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion on the first four days of weeks 1 and 5.
DRUG	Oxaliplatin, calcium folinate, 5-fluorouracil	FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 on the first days of weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion on the first two days of weeks 1, 3 and 5.
PROCEDURE	Esophagectomy	Esophagectomy only in case of residual or recurrent locoregional cancer.

Timeline

• Start date: 2020-11-27
• Primary completion: 2026-12-31
• Completion: 2031-12-31
• First posted: 2020-07-07
• Last updated: 2025-03-06

Locations

12 sites across 5 countries: Canada, Ireland, Norway, Sweden, Taiwan