Phase II study to evaluate the efficacy of 12-month neoadjuvant chemotherapy in terms of disease-free survival in patients with localized digestive neuroendocrine carcinomas - NEONEC D19-01 - NEONEC D19-01

Association Gercor0 个研究点目标入组 78 人开始时间: 2024年7月2日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Histologically proven digestive CNE on biopsy, (the WHO 2017 classification: poorly differentiated and Ki 67 > 20%),, Patients with localized CNE, without metastasis (computed tomography [CT], thoraco-abdominopelvic CT scan [TAP] according to RECIST 1.1; examinations performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),, Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and/or bone disorders,, Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,, Age = 18 years, For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment. Men and women are required to use a reliable and adequate birth control during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration

•Well-differentiated NEC, whatever the grade, Metastatic disease, Cancer of unknown primary, Organ failure that does not allow chemotherapy treatment, History of invasive malignacy disease within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ, Tumor with a mixed component (component accounts for = 30%),, Other than platinum-etoposide chemotherapy administrated,

发起方

Association Gercor