RecruitingPhase 3NCT04460352

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)


Sponsor

Karolinska University Hospital

Enrollment

1,020 participants

Start Date

Nov 27, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment paths for patients with locally advanced squamous cell esophageal cancer (a type of food pipe cancer). One group will have planned surgery after chemoradiotherapy; the other will be watched closely and only have surgery if their cancer returns. The goal is to determine if surgery can safely be avoided in some patients. **You may be eligible if:** - You have confirmed squamous cell esophageal cancer that is locally advanced (not spread to distant organs) - Your cancer is considered removable by your surgical team - You are in good general health (ECOG performance status 0-1) - Your organ function is adequate for treatment - Women of childbearing potential must use highly effective contraception **You may NOT be eligible if:** - Your cancer has spread to distant organs (stage M1) - Your cancer is so advanced it cannot be removed without removing the voice box (laryngectomy) - You have significant heart, kidney, liver, or lung problems that prevent chemotherapy plus radiation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONNeoadjuvant radiotherapy (arm A)

1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.

DRUGCarboplatin, paclitaxel

Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy

PROCEDUREEsophagectomy

Esophagectomy performed within 8 weeks after termination of chemoradiotherapy

RADIATIONNeoadjuvant 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.

DRUGCarboplatin, 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).

DRUGCisplatin, 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.

DRUGOxaliplatin, 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.

PROCEDUREEsophagectomy

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

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NCT04460352


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