Eoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial). - NEEDS

Karolinska University Hospital0 sites1,020 target enrollmentNovember 4, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
Sponsor: Karolinska University Hospital
Enrollment: 1020
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 4, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Karolinska University Hospital

•Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N\+ or cT2\-4a any N, M0
•Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board
•Age \= 18 years and \= 80 years.
•Performance status ECOG 0\-1\.
•Adequate organ function
•Women of childbearing potential 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
•Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment
•Written informed consent
•Are the trial subjects under 18? no

•Distant metastases
•Primary tumor not resectable without laryngectomy.
•Impaired renal, hepatic, cardiac, pulmonary or endocrine status
•Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
•Subjects with previous malignancies
•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.