Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas
NEONEC
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
1 other identifier
interventional
78
1 country
14
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2021
Longer than P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
July 23, 2025
July 1, 2025
6 years
February 11, 2020
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Relapse-free survival (RFS) - phase II
Interval between the date of the start of treatment (chemotherapy) and the date of first relapse or death (all causes). Relapse is defined according to RECIST version 1.1 criteria.
At 12 months
Relapse-free survival (RFS) - prospective cohort
Interval between the date of the start of treatment (chemotherapy) and the date of first relapse or death (all causes). Relapse is defined according to RECIST version 1.1 criteria.
At 12 months
Secondary Outcomes (7)
Number of patient in response in pre-operative or prior radiochemotherapy (if applicable) - Phase II
At 3 months after the beginning of treatment (up to 36 months)
Number of patients who do not benefit from surgery or radiochemotherapy (if applicable) - Phase II
Up to 39 months
Number of patients operated after neoadjuvant chemotherapy or receiving radiochemotherapy (if applicable) - Phase II
Up to 39 months
Overall survival (OS) - Phase II
up to 48 months
Overall survival (OS) - Prospective cohort
Up to 48 months
- +2 more secondary outcomes
Study Arms (2)
Phase II
EXPERIMENTALProspective, open, multi center, one-arm, national phase II study evaluating the benefits in terms of disease-free survival (DFS) at 12 months after the administration of neoadjuvant treatment in patients with localized digestive neuroendocrine carcinomas
Prospective cohort
ACTIVE COMPARATOREvaluation of DFS at 12 months in patients who underwent surgery and received adjuvant chemotherapy
Interventions
4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide followed by surgery or chemoradiotherapy
Surgery (before study entry) followed by 4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide
Eligibility Criteria
You may qualify if:
- Phase II
- Histologically proven digestive CNE, (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, 4. Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,
- \. Age ≥ 18 years, 6. Written informed consent obtained from the patient, willing and able to comply with the protocol, 7. Registration in a National Health Care System (Protection Universelle Maladie \[PUMa\] included), 8. 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.
- Prospective cohort
- Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\> 20%),
- Localized, without metastasis on computed tomography \[CT\], thoracoabdominopelvic CT scan \[TAP\] RECIST 1.1, and/or locoregional lymph node involvement,
- Age ≥ 18 years,
- Written informed consent obtained from the patient, willing and able to comply with the protocol,
- Registration in a National Health Care System (PUMa - Protection Universelle Maladie included),
- 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 methods during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.
You may not qualify if:
- Phase II
- Well-differentiated NEC, whatever the grade,
- Metastatic disease,
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment,
- Previous malignancy 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%),
- Patient impossible to follow-up,
- Other than platinum-etoposide chemotherapy administrated,
- Tutelage or guardianship or patient protected by law
- Prospective cohort
- Well-differentiated NEC, whatever the grade,
- Metastatic disease,
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment,
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 75012, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna PELLAT
Saint-Antoine Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 13, 2020
Study Start
January 5, 2021
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2031
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share