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).
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,
Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67> 20%),
Well-differentiated NEC, whatever the grade,
Metastatic disease,
Cancer of unknown primary
Organ failure that does not allow chemotherapy treatment,
Parallel
Neoadjuvant treatment
Drug4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide followed by surgery or chemoradiotherapy
Adjuvant treatment
DrugSurgery (before study entry) followed by 4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide
Relapse-free survival (RFS) - phase II
Interval between the date of the start of treatment (chemotherapy) and the date of first relapse or death (all causes). Relapse is defined according to RECIST version 1.1 criteria.
Relapse-free survival (RFS) - prospective cohort
Interval between the date of the start of treatment (chemotherapy) and the date of first relapse or death (all causes). Relapse is defined according to RECIST version 1.1 criteria.
Number of patient in response in pre-operative or prior radiochemotherapy (if applicable) - Phase II
according to RECIST 1.1
Number of patients who do not benefit from surgery or radiochemotherapy (if applicable) - Phase II
Number of patients who do not benefit from surgery or radiochemotherapy (if applicable) - Phase II
Number of patients operated after neoadjuvant chemotherapy or receiving radiochemotherapy (if applicable) - Phase II
Number of patients operated after neoadjuvant chemotherapy or receiving
Overall survival (OS) - Phase II
Overall survival (OS) is defined as the time from study enrollment to death (from any cause) or to the last date the patients was known to be alive.
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GERCOR - Multidisciplinary Oncology Cooperative Group
Lead sponsor
Fondation ARCAD
Collaborator
