Spots Global Cancer Trial Database for Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

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Trial Identification

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

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

Study ID: NCT04460352

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Neoadjuvant radiotherapy (arm A)

Carboplatin, paclitaxel

Esophagectomy

Neoadjuvant radiotherapy (arm B)

Carboplatin, paclitaxel

Cisplatin, paclitaxel

Oxaliplatin, calcium folinate, 5-fluorouracil

Esophagectomy

Study Description

Brief 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.

Detailed Description: