Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas
Recruiting
Phase 2
Interventional Study
Neuroendocrine Carcinoma
Digestive Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group · Other
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About This Trial
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.
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Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Phase II
1. Histologically proven digestive CNE, (the WHO 2017 classification: poorly differentiated and Ki 67 \> 20%),
2. Patients with localized CNE, without metastasis (computed tomography \[CT\], thoraco-abdominopelvic CT scan \[TAP\] according to RECIST 1.1; examinations p…
Contacts