Evaluate the efficacy of 12-month neoadjuvant chemotherapy in terms ofdisease-free survival in patients with localized digestive neuroendocrinecarcinomas

Phase 1

• Conditions: ocalized digestive Neuroendocrine Carcinomas; MedDRA version: 21.0Level: LLTClassification code: 10062476Term: Neuroendocrine tumor Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-515603-19-00
• Lead Sponsor: Association Gercor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Histologically proven digestive CNE on biopsy, (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,, Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,, Age = 18 years, 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

Exclusion Criteria

Well-differentiated NEC, whatever the grade, Metastatic disease, Cancer of unknown primary, Organ failure that does not allow chemotherapy treatment, History of invasive malignacy disease within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ, Tumor with a mixed component (component accounts for = 30%),, Other than platinum-etoposide chemotherapy administrated,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified