Actively Recruiting
Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer
Led by Karolinska University Hospital · Updated on 2025-03-06
1020
Participants Needed
12
Research Sites
578 weeks
Total Duration
On this page
Sponsors
K
Karolinska University Hospital
Lead Sponsor
U
University of Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed squamous cell carcinoma of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0
- Technically resectable disease confirmed by local multidisciplinary team
- Performance status ECOG 0-1
- Adequate organ function
- Negative pregnancy test for women of childbearing potential
- Use of effective birth control during treatment and for at least five months after last study treatment for patients of reproductive potential
- Discontinuation of nursing for female subjects who are breastfeeding
- No psychological, familial, sociological, or geographical conditions hampering study compliance
- Written informed consent given according to regulations
You will not qualify if you...
- Presence of distant metastases (M1) or tumor stage cT4b
- Primary tumor not resectable without laryngectomy
- Impaired renal, hepatic, cardiac, pulmonary, or endocrine function compromising treatment eligibility
- Unlikely to tolerate multimodality treatment with chemoradiotherapy and esophagectomy
- Previous malignancies unless complete remission or resection achieved at least 5 years prior
- Prior or concurrent radiotherapy or chemoradiotherapy overlapping treatment fields
- Known uncontrollable hypersensitivity to chemotherapy components used in the trial
- Inability to understand or comply with study instructions due to language difficulties or cognitive impairments such as dementia or severe psychiatric disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
McGill University Health Centre
Montreal, Quebec, Canada
Actively Recruiting
2
Cancer Clinical Trials Unit (CCTU) at St. James's Hospital
Dublin, Dublin, Ireland, D08 NHY1
Actively Recruiting
3
Oslo universitetssykehus
Oslo, Norway
Actively Recruiting
4
Universitetssykehuset Nord-Norge
Tromsø, Norway
Actively Recruiting
5
St Olavs Hospital
Trondheim, Norway
Actively Recruiting
6
Linköpings universitetssjukhus
Linköping, Sweden
Actively Recruiting
7
Skånes universitetssjukhus
Lund, Sweden
Actively Recruiting
8
Örebro universitetssjukhus
Örebro, Sweden
Actively Recruiting
9
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
10
Norrlands universitetssjukhus
Umeå, Sweden
Actively Recruiting
11
Akademiska sjukhuset
Uppsala, Sweden
Actively Recruiting
12
Chang Gung Memorial Hospital
Linkou District, Taiwan
Actively Recruiting
Research Team
M
Magnus Nilsson, MD, PhD
CONTACT
M
Mats Hellström
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here