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).
A total of 48 patients is to be included in phase II and 30 patients in prospective cohort during the inclusion period of phase II. Phase II study treatment: Neoadjuvant chemotherapy: Administration of 4 cycles of chemotherapy (3 months) with platinum based chemotherapy (carboplatin or cisplatin, at the choice of the investigator) + etoposide. Surgery or chemoradiotherapy depending on the tumor localization (the irradiation modalities and associated chemotherapy treatment will be left to the discretion of the referring radiotherapists according to current recommendations for each localization). Prospective cohort: * Surgery (prior to study entry) * Adjuvant chemotherapy : Administration of 4 cycles of chemotherapy (3 months) with platinum based chemotherapy (carboplatin or cisplatin, at the choice of the investigator) + etoposide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide followed by surgery or chemoradiotherapy
Surgery (before study entry) followed by 4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide
CHU Amiens - Hôpital Sud
Amiens, France
RECRUITINGCHU Jean Minjoz
Besançon, France
RECRUITINGHôpital Beaujon
Clichy, France
RECRUITINGCHU Dijon
Dijon, France
RECRUITINGHôpital Edouard Herriot
Lyon, France
NOT_YET_RECRUITINGInstitut Paoli-Calmettes
Marseille, France
NOT_YET_RECRUITINGSaint Antoine Hospital
Paris, France
RECRUITINGGroupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
NOT_YET_RECRUITINGHôpital Cochin
Paris, France
NOT_YET_RECRUITINGHôpital Saint Antoine
Paris, France
RECRUITING...and 4 more locations
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.
Time frame: At 12 months
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.
Time frame: At 12 months
Number of patient in response in pre-operative or prior radiochemotherapy (if applicable) - Phase II
according to RECIST 1.1
Time frame: At 3 months after the beginning of treatment (up to 36 months)
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
Time frame: Up to 39 months
Number of patients operated after neoadjuvant chemotherapy or receiving radiochemotherapy (if applicable) - Phase II
Number of patients operated after neoadjuvant chemotherapy or receiving
Time frame: Up to 39 months
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.
Time frame: up to 48 months
Overall survival (OS) - Prospective cohort
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.
Time frame: Up to 48 months
Number of participants with treatment-related adverse events grade 3-4 as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 - Phase II
Patients will be assessed for AEs throughout the study at every visit during treatment. Investigators using the NCI-CTCAE version 5.0 will grade the severity of AEs. Institute Common Terminology Criteria for Adverse Toxicity Study (NCI-CTCAE) version 5.0
Time frame: Up to 43 months
Number of participants with treatment-related adverse events grade 3-4 as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 - Prospective cohort
Patients will be assessed for AEs throughout the study at every visit during treatment. Investigators using the NCI-CTCAE version 5.0 will grade the severity of AEs. Institute Common Terminology Criteria for Adverse Toxicity Study (NCI-CTCAE) version 5.0
Time frame: Up to 43 months
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