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Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2021-01-05
Completion Date
2031-01
Last Updated
2025-07-23
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant treatment
4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide followed by surgery or chemoradiotherapy
Adjuvant treatment
Surgery (before study entry) followed by 4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide
Locations (14)
CHU Amiens - Hôpital Sud
Amiens, France
CHU Jean Minjoz
Besançon, France
Hôpital Beaujon
Clichy, France
CHU Dijon
Dijon, France
Hôpital Edouard Herriot
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Saint Antoine Hospital
Paris, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
Hôpital Cochin
Paris, France
Hôpital Saint Antoine
Paris, France
Hôpital Haut Lévêque CHU Bordeaux
Pessac, France
CHU Poitiers
Poitiers, France
CHU Toulouse
Toulouse, France
Institut Gustave Roussy
Villejuif, France