Neoadjuvant chemotherapy for localized digestive neuroendocrine carcinomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the efficacy of a 12-month neoadjuvant chemotherapy regimen in patients with localized digestive neuroendocrine carcinomas (NEC). The treatment involves four cycles of platinum-based chemotherapy combined with etoposide, followed by surgery or chemoradiotherapy based on tumor location. Additionally, a prospective cohort study will assess patients who undergo surgery without prior neoadjuvant treatment and receive adjuvant chemotherapy. The primary goal is to improve relapse-free survival in these patients.

Why it matters

Who can join: the full rules

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 performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),
3. 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 surgical consultation meeting,

5\. Age ≥ 18 years, 6. Written informed consent obtained from the patient, willing and able to comply with the protocol, 7. Registration in a National Health Care System (Protection Universelle Maladie \[PUMa\] included), 8. 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.

Prospective cohort

1. Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\> 20%),
2. Localized, without metastasis on computed tomography \[CT\], thoracoabdominopelvic CT scan \[TAP\] RECIST 1.1, and/or locoregional lymph node involvement,
3. Age ≥ 18 years,
4. Written informed consent obtained from the patient, willing and able to comply with the protocol,
5. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included),
6. 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 (if applicable) during the period of treatment and during 6 months from the last treatment administration.

Exclusion Criteria:

Phase II

1. Well-differentiated NEC, whatever the grade,
2. Metastatic disease,
3. Cancer of unknown primary
4. Organ failure that does not allow chemotherapy treatment,
5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ
6. Tumor with a mixed component (component accounts for ≥ 30%),
7. Patient impossible to follow-up,
8. Other than platinum-etoposide chemotherapy administrated,
9. Tutelage or guardianship or patient protected by law

Prospective cohort

1. Well-differentiated NEC, whatever the grade,
2. Metastatic disease,
3. Cancer of unknown primary
4. Organ failure that does not allow chemotherapy treatment,
5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ
6. Tumor with a mixed component (component accounts for ≥ 30%),
7. Patient impossible to follow-up,
8. Other than platinum-etoposide chemotherapy administrated,
9. Tutelage or guardianship or patient protected by law.

Where it's running

• CHU Amiens - Hôpital Sud
  Amiens, France Recruiting
• CHU Jean Minjoz
  Besançon, France Recruiting
• Hôpital Beaujon
  Clichy, France Recruiting
• CHU Dijon
  Dijon, France Recruiting
• Saint Antoine Hospital
  Paris, France Recruiting
• Hôpital Saint Antoine
  Paris, France Recruiting

Study contacts

• Principal investigator: Anna PELLAT — Saint-Antoine Hospital
• Study coordinator: Anna PELLAT, MD
• Email: anna.pellat@aphp.fr
• Phone: +33 (0) 1 49 28 23 45

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.