Status:
RECRUITING
Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
University of Leipzig
The Swedish Research Council
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.
- Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
- Performance status ECOG 0-1.
- Adequate organ function.
- Women of childbearing potential (WOCBP\*) must have a negative serum or urine pregnancy test.
- Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment.
- Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations.
Exclusion
- M1 according to current (8th) version of of the AJCC TNM classification.
- cT4b according to current (8th) version of of the AJCC TNM classification.
- Primary tumor not resectable without laryngectomy.
- Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.
- Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
- Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
- Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields.
- Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens.
- Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder.
- (Criteria slightly shortened)
Key Trial Info
Start Date :
November 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT04460352
Start Date
November 27 2020
End Date
December 31 2031
Last Update
March 6 2025
Active Locations (12)
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1
McGill University Health Centre
Montreal, Quebec, Canada
2
Cancer Clinical Trials Unit (CCTU) at St. James's Hospital
Dublin, Dublin, Ireland, D08 NHY1
3
Oslo universitetssykehus
Oslo, Norway
4
Universitetssykehuset Nord-Norge
Tromsø, Norway