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

Karolinska University Hospital0 个研究点目标入组 1,020 人开始时间: 2020年11月4日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•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
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 480
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 612

•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.

发起方

Karolinska University Hospital