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

Prior treatment

• Other than platinum-etoposide chemotherapy administrated,
• Other than platinum-etoposide chemotherapy administrated,

Other illness

• 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
• 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

Other

• Phase II
• Well-differentiated NEC, whatever the grade,
• Tumor with a mixed component (component accounts for ≥ 30%),
• Patient impossible to follow-up,
• Tutelage or guardianship or patient protected by law
  • Prospective cohort
• Well-differentiated NEC, whatever the grade,
• Tumor with a mixed component (component accounts for ≥ 30%),
• Patient impossible to follow-up,
• Tutelage or guardianship or patient protected by law.

• 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.
  • 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.