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Neuroendocrine CarcinomaPhase 2NEONECNCT04268121

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

A Phase 2 study testing Neoadjuvant treatment and Adjuvant treatment in people with Neuroendocrine Carcinoma and Digestive Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 14 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Carcinoma, Digestive Cancer
What is being tested?
Neoadjuvant treatment and Adjuvant treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
14 sitesFrance
Study dates
5 Jan 2021to Jan 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
  • 5. 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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,
  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna PELLAT, MD contact

+33 (0) 1 49 28 23 45

anna.pellat@aphp.fr

Marie-Line GARCIA-LARNICOL contact

marie-line.garcia-larnicol@gercor.com.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • CHU Amiens - Hôpital Sud

    Amiens

    Vincent HAUTEFEUILLE, MD, +33(0)322088854, hautefeuille.vincent@chu-amiens.fr

    Vincent HAUTEFEUILLE, MD

    Recruiting

  • CHU Jean Minjoz

    Besançon

    Fabien CALCAGNO, MD, +33(03)70632153, fabien.calcagno@gmail.com

    Fabien CALCAGNO, MD

    Recruiting

  • Hôpital Beaujon

    Clichy

    Olivia HENTIC, MD, + 33 (0)1 40 87 52 41, olivia.hentic@aphp.fr

    Olivia HENTIC, MD

    Recruiting

  • CHU Dijon

    Dijon

    Côme LEPAGE, MD, +33 (0)3 80 39 33 40, come.lepage@u-bourgogne.fr

    Côme LEPAGE, MD

    Recruiting

  • Hôpital Edouard Herriot

    Lyon

    Thomas WALTER, MD

    Thomas WALTER, MD

    Not yet recruiting

  • Institut Paoli-Calmettes

    Marseille

    Patricia NICCOLI, MD

    Patricia NICCOLI, MD

    Not yet recruiting

  • Saint Antoine Hospital

    Paris, 75012

    Anna PELLAT, +33 (0) 1 49 28 23 45, anna.pellat@aphp.fr

    Pauline AFCHAIN, +33 (0) 1 49 28 23 45, pauline.afchain@aphp.fr

    Recruiting

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris

    Olivier DUBREUIL, MD

    Olivier DUBREUIL, MD

    Not yet recruiting

  • Hôpital Cochin

    Paris

    Romain CORIAT, md

    Romain CORIAT, MD

    Not yet recruiting

  • Hôpital Saint Antoine

    Paris

    Pauline AFCHAIN, MD, +33 (0)1 49 28 23 29, pauline.afchain@aphp.fr

    Pauline AFCHAIN, MD

    Recruiting

  • Hôpital Haut Lévêque CHU Bordeaux

    Pessac

    Denis SMITH, MD, + 33 (0)5 57 65 64 39, denis.smith@chu-bordeaux.fr

    Denis SMITH, MD

    Recruiting

  • CHU Poitiers

    Poitiers

    David TOUGERON, MD, +33(05)49443751, David.TOUGERON@chu-poitiers.fr

    David TOUGERON, MD

    Recruiting

  • CHU Toulouse

    Toulouse

    Rosine GUIMBAUD, MD, +33 (0)561779649, guimbaud.r@chu-toulouse.fr

    Rosine GUIMBAUD, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Michel DUCREUX, MD

    Michel DUCREUX, MD

    Not yet recruiting

Other trials in France

About this study

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

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).

Read the detailed description

A total of 48 patients is to be included in phase II and 30 patients in prospective cohort during the inclusion period of phase II.

Phase II study treatment:

Neoadjuvant chemotherapy: Administration of 4 cycles of chemotherapy (3 months) with platinum based chemotherapy (carboplatin or cisplatin, at the choice of the investigator) + etoposide.

Surgery or chemoradiotherapy depending on the tumor localization (the irradiation modalities and associated chemotherapy treatment will be left to the discretion of the referring radiotherapists according to current recommendations for each localization).

Prospective cohort:

  • Surgery (prior to study entry)
  • Adjuvant chemotherapy : Administration of 4 cycles of chemotherapy (3 months) with platinum based chemotherapy (carboplatin or cisplatin, at the choice of the investigator) + etoposide.
Being tested
Neoadjuvant treatment, Adjuvant treatment
Keywords
Neoadjuvant treatment, Adjuvant treatment
Medical subject headings
Carcinoma, Neuroendocrine, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant treatmentDrug

    Also called cisplatin / cisplatinum, etoposide / vepesid, carbopatin / paraplatin

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

  • Adjuvant treatmentDrug

    Also called cisplatin / cisplatinum, etoposide / vepesid, carbopatin / paraplatin

    Surgery (before study entry) followed by 4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide

Study groups in NCT04268121
Study groupRoleWhat they receive
Phase IIExperimentalProspective, 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
Receives: Drug: Neoadjuvant treatment
Prospective cohortActive comparatorEvaluation of DFS at 12 months in patients who underwent surgery and received adjuvant chemotherapy
Receives: Drug: Adjuvant treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 months

  2. 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.

    Measured: At 12 months

Secondary outcomes (7)

  1. Number of patient in response in pre-operative or prior radiochemotherapy (if applicable) - Phase II

    according to RECIST 1.1

    Measured: At 3 months after the beginning of treatment (up to 36 months)

  2. Number of patients who do not benefit from surgery or radiochemotherapy (if applicable) - Phase II

    Number of patients who do not benefit from surgery or radiochemotherapy (if applicable) - Phase II

    Measured: Up to 39 months

  3. Number of patients operated after neoadjuvant chemotherapy or receiving radiochemotherapy (if applicable) - Phase II

    Number of patients operated after neoadjuvant chemotherapy or receiving

    Measured: Up to 39 months

  4. Overall survival (OS) - Phase II

    Overall survival (OS) is defined as the time from study enrollment to death (from any cause) or to the last date the patients was known to be alive.

    Measured: up to 48 months

  5. Overall survival (OS) - Prospective cohort

    Overall survival (OS) is defined as the time from study enrollment to death (from any cause) or to the last date the patients was known to be alive.

    Measured: Up to 48 months

  6. Number of participants with treatment-related adverse events grade 3-4 as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 - Phase II

    Patients will be assessed for AEs throughout the study at every visit during treatment. Investigators using the NCI-CTCAE version 5.0 will grade the severity of AEs.

    Institute Common Terminology Criteria for Adverse Toxicity Study (NCI-CTCAE) version 5.0

    Measured: Up to 43 months

  7. Number of participants with treatment-related adverse events grade 3-4 as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 - Prospective cohort

    Patients will be assessed for AEs throughout the study at every visit during treatment. Investigators using the NCI-CTCAE version 5.0 will grade the severity of AEs.

    Institute Common Terminology Criteria for Adverse Toxicity Study (NCI-CTCAE) version 5.0

    Measured: Up to 43 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start5 Jan 2021
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Phase II and prospective cohort
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268121
Sponsor's protocol ID
NEONEC D19-01
Acronym
NEONEC
Status last verified
Jul 2025
First submitted
11 Feb 2020
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant treatment and Adjuvant treatment in people with Neuroendocrine Carcinoma and Digestive Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna PELLAT, MD (+33 (0) 1 49 28 23 45, anna.pellat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival (RFS) - phase II (time frame: At 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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