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RECRUITING
NCT04460352
PHASE3

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

Sponsor: Karolinska University Hospital

View on ClinicalTrials.gov

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

Interventions

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.

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