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Tests treatment safety and results for Neuroendocrine Carcinoma
Official title Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas
ClinicalTrials.gov ID: NCT04268121
What this study is testing
What is Neoadjuvant treatment?
Neoadjuvant treatment is an investigational medicine, being studied as a potential treatment for neuroendocrine carcinoma.
Also referred to as cisplatin / cisplatinum, etoposide / vepesid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase II
- 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...
- Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and/or bone disorders, 4. Resectable tumor...
- Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\>...
You likely can't join if
- Phase II
- Well-differentiated NEC, whatever the grade,
- Metastatic disease,
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment,
- Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ
See the full eligibility criteria
- Phase II
- 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...
- 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...
- Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\> 20%),
- Localized, without metastasis on computed tomography [CT], thoracoabdominopelvic CT scan [TAP] RECIST 1.1, and/or locoregional lymph node involvement,
- Age ≥ 18 years,
- Written informed consent obtained from the patient, willing and able to comply with the protocol,
- Registration in a National Health Care System (PUMa - Protection Universelle Maladie included),
- 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 methods during the study...
- Phase II
- Well-differentiated NEC, whatever the grade,
- Metastatic disease,
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment,
- Previous malignancy 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%),
- Patient impossible to follow-up,
- Other than platinum-etoposide chemotherapy administrated,
- Tutelage or guardianship or patient protected by law Prospective cohort
- Well-differentiated NEC, whatever the grade,
- Metastatic disease,
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment,
- Previous malignancy 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%),
- Patient impossible to follow-up,
- Other than platinum-etoposide chemotherapy administrated,
- Tutelage or guardianship or patient protected by law.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Besançon, France
- Clichy, France
- Dijon, France
- Lyon, France
- Marseille, France
- Paris, France
- Pessac, France
- Poitiers, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Besançon, France; Clichy, France; Dijon, France; Lyon, France; Marseille, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.