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Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas

Study acronym: NEONEC
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jan 2034 to Jan 2027
    • Study completion date: Jun 2034 to Jan 2031
    v9
  2. Primary completion date: Mar 2023 to Jan 2034
    • Study completion date: Mar 2024 to Jun 2034
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2020 to Jan 5, 2021
    • Secondary endpoints revised (7)
    v6
  5. Start date: Jul 2020 to Sep 2020v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: May 2020 to Jul 2020v4
  2. Start date: Feb 2020 to May 2020v3
  3. Primary endpoints revised (2)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04268121
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Fondation ARCAD
Conditions
(from sponsor)		 Neuroendocrine Carcinoma, Digestive Cancer
Related terms Carcinoma, Neuroendocrine, Gastrointestinal Neoplasms
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov