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Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer
Sponsor: Karolinska University Hospital
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.
Official title: NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1020
Start Date
2020-11-27
Completion Date
2031-12-31
Last Updated
2025-03-06
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant radiotherapy (arm A)
1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.
Carboplatin, paclitaxel
Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy
Esophagectomy
Esophagectomy performed within 8 weeks after termination of chemoradiotherapy
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.
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).
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.
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.
Esophagectomy
Esophagectomy only in case of residual or recurrent locoregional cancer.
Locations (12)
McGill University Health Centre
Montreal, Quebec, Canada
Cancer Clinical Trials Unit (CCTU) at St. James's Hospital
Dublin, Dublin, Ireland
Oslo universitetssykehus
Oslo, Norway
Universitetssykehuset Nord-Norge
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Linköpings universitetssjukhus
Linköping, Sweden
Skånes universitetssjukhus
Lund, Sweden
Örebro universitetssjukhus
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
Norrlands universitetssjukhus
Umeå, Sweden
Akademiska sjukhuset
Uppsala, Sweden
Chang Gung Memorial Hospital
Linkou District, Taiwan