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

Phase 1

• Conditions: Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500966-82-00
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1010

Inclusion Criteria

Histopathologically confirmed squamous cell carcinoma 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., Performance status ECOG 0-1., Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to randomisation., Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least six months after the last study treatment., Before patient registration/randomisation, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations., Age = 18 years and = 80 years., Adequate organ function, Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment

Exclusion Criteria

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 with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry., 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., Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified