Actively Recruiting
Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas
Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2025-07-23
78
Participants Needed
14
Research Sites
521 weeks
Total Duration
On this page
Sponsors
G
GERCOR - Multidisciplinary Oncology Cooperative Group
Lead Sponsor
F
Fondation ARCAD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed poorly differentiated digestive neuroendocrine carcinoma with Ki 67 > 20% according to WHO 2017
- Localized neuroendocrine carcinoma without metastasis confirmed by CT and PET scans
- Resectable tumor based on multidisciplinary surgical assessment
- Age 18 years or older
- Written informed consent and willingness to comply with study protocol
- Registered in National Health Care System (PUMa included)
- For women of childbearing potential, negative pregnancy test within 7 days before treatment start
- Use of reliable birth control during treatment and for 6 months after last treatment if applicable
You will not qualify if you...
- Well-differentiated neuroendocrine carcinoma of any grade
- Presence of metastatic disease
- Cancer of unknown primary origin
- Organ failure preventing chemotherapy administration
- Previous malignancy within 5 years except cutaneous basal cell carcinoma and uterine cancer in situ
- Tumor with mixed component ≥ 30%
- Inability to follow-up
- Prior chemotherapy other than platinum-etoposide
- Under legal guardianship or patient protected by law
AI-Screening
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Trial Site Locations
Total: 14 locations
1
CHU Amiens - Hôpital Sud
Amiens, France
Actively Recruiting
2
CHU Jean Minjoz
Besançon, France
Actively Recruiting
3
Hôpital Beaujon
Clichy, France
Actively Recruiting
4
CHU Dijon
Dijon, France
Actively Recruiting
5
Hôpital Edouard Herriot
Lyon, France
Not Yet Recruiting
6
Institut Paoli-Calmettes
Marseille, France
Not Yet Recruiting
7
Saint Antoine Hospital
Paris, France, 75012
Actively Recruiting
8
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
Not Yet Recruiting
9
Hôpital Cochin
Paris, France
Not Yet Recruiting
10
Hôpital Saint Antoine
Paris, France
Actively Recruiting
11
Hôpital Haut Lévêque CHU Bordeaux
Pessac, France
Actively Recruiting
12
CHU Poitiers
Poitiers, France
Actively Recruiting
13
CHU Toulouse
Toulouse, France
Actively Recruiting
14
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
A
Anna PELLAT, MD
CONTACT
M
Marie-Line GARCIA-LARNICOL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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