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

Last updated: June 28, 2023
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Overall Status: Active - Recruiting

Phase

2

Condition

Neuroendocrine Carcinoma

Carcinoma

Treatment

Neoadjuvant treatment

Adjuvant treatment

Clinical Study ID

NCT04268121
NEONEC D19-01
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Phase II

  1. Histologically proven digestive CNE, (the WHO 2017 classification: poorlydifferentiated and Ki 67 > 20%),
  2. Patients with localized CNE, without metastasis (computed tomography [CT],thoraco-abdominopelvic CT scan [TAP] according to RECIST 1.1; examinations performedno later than 21 days before starting the study treatment, possible locoregional lymphnode involvement defined according to the TNM classification),
  3. Positron emission tomography (PET) and CT for lymph node status and elimination ofsecondary visceral and/or bone disorders, 4. Resectable tumor, according to theconsensus decision made during local multidisciplinary surgical consultation meeting,
  4. Age ≥ 18 years, 6. Written informed consent obtained from the patient, willing and ableto comply with the protocol, 7. Registration in a National Health Care System (ProtectionUniverselle 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 treatmentadministration. Prospective cohort
  5. Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67> 20%),
  6. Localized, without metastasis on computed tomography [CT], thoracoabdominopelvic CTscan [TAP] RECIST 1.1, and/or locoregional lymph node involvement,
  7. Age ≥ 18 years,
  8. Written informed consent obtained from the patient, willing and able to comply withthe protocol,
  9. Registration in a National Health Care System (PUMa - Protection Universelle Maladieincluded),
  10. For female patients of childbearing potential, negative pregnancy test within 7 daysbefore starting the study treatment. Men and women are required to use a reliable and adequate birth control methods during thestudy (if applicable) during the period of treatment and during 6 months from the lasttreatment administration.

Exclusion

Exclusion Criteria: Phase II

  1. Well-differentiated NEC, whatever the grade,
  2. Metastatic disease,
  3. Cancer of unknown primary
  4. Organ failure that does not allow chemotherapy treatment,
  5. Previous malignancy within 5 years prior to the study except for cutaneous basal cellcarcinoma and uterine cancer in situ
  6. Tumor with a mixed component (component accounts for ≥ 30%),
  7. Patient impossible to follow-up,
  8. Other than platinum-etoposide chemotherapy administrated,
  9. Tutelage or guardianship or patient protected by law Prospective cohort
  10. Well-differentiated NEC, whatever the grade,
  11. Metastatic disease,
  12. Cancer of unknown primary
  13. Organ failure that does not allow chemotherapy treatment,
  14. Previous malignancy within 5 years prior to the study except for cutaneous basal cellcarcinoma and uterine cancer in situ
  15. Tumor with a mixed component (component accounts for ≥ 30%),
  16. Patient impossible to follow-up,
  17. Other than platinum-etoposide chemotherapy administrated,
  18. Tutelage or guardianship or patient protected by law.

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Neoadjuvant treatment
Phase: 2
Study Start date:
January 05, 2021
Estimated Completion Date:
June 30, 2034

Study 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.

Connect with a study center

  • CHU Amiens - Hôpital Sud

    Amiens,
    France

    Active - Recruiting

  • CHU Jean Minjoz

    Besançon,
    France

    Active - Recruiting

  • Hôpital Beaujon

    Clichy,
    France

    Active - Recruiting

  • CHU Dijon

    Dijon,
    France

    Active - Recruiting

  • Hôpital Edouard Herriot

    Lyon,
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille,
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris,
    France

    Site Not Available

  • Hôpital Cochin

    Paris,
    France

    Site Not Available

  • Hôpital Saint Antoine

    Paris,
    France

    Active - Recruiting

  • Saint Antoine Hospital

    Paris, 75012
    France

    Active - Recruiting

  • Hôpital Haut Lévêque CHU Bordeaux

    Pessac,
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.