Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs. Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date. The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Patient treated with a combination Folfiri-bevacizumab. Treatment every 2 weeks (D1 = D15)
Patient treated with Folfiri only. Treatment every 2 weeks (D1 = D15)
Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Sud, CHU d'Amiens
Amiens, France
Service d'Hépatogastroentérologie, CHU d'Angers
Angers, France
Service d'Oncologie et Radiothérapie, Institut Sainte Catherine
Avignon, France
Service de Gastroentérologie et Oncologie Digestive, Hôpital Avicenne
Bobigny, France
Service de Gastroentérologie et Pancréatologie, Hôpital Beaujon, APHP
Clichy, France
Proportion of patients alive
The primary endpoint is the proportion of patients alive 6 months after treatment
Time frame: 6 months after treatment
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Service de Gastroentérologie, CHU Henri Mondor
Créteil, France
Service d'Hépato-Gastroentérologie et Oncologie Digestive, CHU de Dijon
Dijon, France
Service d'Hépatogastroentéologie, Hôpital Michallon, CHU de Grenoble
Grenoble, France
Département de Cancérologie Urologique et Digestive, Centre Oscar Lambret
Lille, France
Département de cancérologie médicale - Groupe des tumeurs endocrines, Centre Léon Bérard
Lyon, France
...and 16 more locations