Phase
Condition
Neuroendocrine Carcinoma
Carcinoma
Treatment
Neoadjuvant treatment
Adjuvant treatment
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Phase II
- Histologically proven digestive CNE, (the WHO 2017 classification: poorlydifferentiated and Ki 67 > 20%),
- 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),
- 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,
- 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
- 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 CTscan [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 withthe protocol,
- Registration in a National Health Care System (PUMa - Protection Universelle Maladieincluded),
- 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
- 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 cellcarcinoma 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,
- Previous malignancy within 5 years prior to the study except for cutaneous basal cellcarcinoma 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.
Study Design
Study Description
Connect with a study center
CHU Amiens - Hôpital Sud
Amiens,
FranceActive - Recruiting
CHU Jean Minjoz
Besançon,
FranceActive - Recruiting
Hôpital Beaujon
Clichy,
FranceActive - Recruiting
CHU Dijon
Dijon,
FranceActive - Recruiting
Hôpital Edouard Herriot
Lyon,
FranceSite Not Available
Institut Paoli-Calmettes
Marseille,
FranceSite Not Available
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris,
FranceSite Not Available
Hôpital Cochin
Paris,
FranceSite Not Available
Hôpital Saint Antoine
Paris,
FranceActive - Recruiting
Saint Antoine Hospital
Paris, 75012
FranceActive - Recruiting
Hôpital Haut Lévêque CHU Bordeaux
Pessac,
FranceActive - Recruiting
CHU Poitiers
Poitiers,
FranceActive - Recruiting
CHU Toulouse
Toulouse,
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif,
FranceSite Not Available
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