Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 2
GERCOR - Multidisciplinary Oncology Cooperative Group (Voir sur ClinicalTrials)
janvier 2021
janvier 2031
24 juillet 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 18/02/2024 16:37:50 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Olivia HENTIC, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Romain CORIAT, md | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Pauline AFCHAIN, MD | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Olivier DUBREUIL, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens - Hôpital Sud - Amiens - France | Vincent HAUTEFEUILLE, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon - France | Côme LEPAGE, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minjoz - Besançon - France | Fabien CALCAGNO, MD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | David TOUGERON, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Rosine GUIMBAUD, MD | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - Lyon - France | Thomas WALTER, MD | Contact (sur clinicalTrials) | |||
| Hôpital Haut Lévêque CHU Bordeaux - Pessac - France | Denis SMITH, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - Marseille - France | Patricia NICCOLI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Phase II
1. Histologically proven digestive CNE, (the WHO 2017 classification: poorly
differentiated 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 performed
no later than 21 days before starting the study treatment, possible locoregional
lymph node involvement defined according to the TNM classification),
3. 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
1. Patients with localized digestive CNE histologically proven on the operative
specimen (the WHO 2017 classification: poorly differentiated and Ki 67> 20%),
2. Localized, without metastasis on computed tomography [CT], thoracoabdominopelvic CT
scan [TAP] RECIST 1.1, and/or locoregional lymph node involvement,
3. Age ≥ 18 years,
4. Written informed consent obtained from the patient, willing and able to comply with
the protocol,
5. Registration in a National Health Care System (PUMa - Protection Universelle Maladie
included),
6. 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.
Phase II
1. Histologically proven digestive CNE, (the WHO 2017 classification: poorly
differentiated 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 performed
no later than 21 days before starting the study treatment, possible locoregional
lymph node involvement defined according to the TNM classification),
3. 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
1. Patients with localized digestive CNE histologically proven on the operative
specimen (the WHO 2017 classification: poorly differentiated and Ki 67> 20%),
2. Localized, without metastasis on computed tomography [CT], thoracoabdominopelvic CT
scan [TAP] RECIST 1.1, and/or locoregional lymph node involvement,
3. Age ≥ 18 years,
4. Written informed consent obtained from the patient, willing and able to comply with
the protocol,
5. Registration in a National Health Care System (PUMa - Protection Universelle Maladie
included),
6. 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.
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
cell carcinoma 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
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
cell carcinoma 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.