drugset / Trial / NCT04268121

Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas

NCT04268121 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery. The objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy. In parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide).

Timeline

Start
2021-01-05
Primary completion
2027-01
Completion
2031-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Cisplatin Other / unclassified — —
Subject Etoposide Small molecule — —