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RECRUITING
NCT04268121
PHASE2

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

Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

View on ClinicalTrials.gov

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

Interventions

DRUG

Neoadjuvant treatment

4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide followed by surgery or chemoradiotherapy

DRUG

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