Neoadjuvant chemotherapy for localized digestive neuroendocrine carcinomas

Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas

This study is testing a new 12-month chemotherapy treatment for people with localized digestive neuroendocrine carcinomas to see if it helps them live longer without the cancer coming back after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 14 sites (Amiens and 13 other locations)
• Trial ID: NCT04268121 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically proven localized digestive neuroendocrine carcinomas that are resectable and without metastasis.

Not a fit: Patients with metastatic neuroendocrine carcinomas or those with tumors deemed unresectable will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance relapse-free survival rates for patients with localized digestive neuroendocrine carcinomas.

How similar studies have performed: Other studies have shown promise with neoadjuvant chemotherapy approaches in similar cancer types, suggesting potential for success in this trial.

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 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 this trial is running

Amiens and 13 other locations

• CHU Amiens - Hôpital Sud — Amiens, France (Recruiting)
• CHU Jean Minjoz — Besançon, France (Recruiting)
• Hôpital Beaujon — Clichy, France (Recruiting)
• CHU Dijon — Dijon, France (Recruiting)
• Hôpital Edouard Herriot — Lyon, France (Not_yet_recruiting)
• Institut Paoli-Calmettes — Marseille, France (Not_yet_recruiting)
• Saint Antoine Hospital — Paris, France (Recruiting)
• Groupe Hospitalier Diaconesses Croix Saint Simon — Paris, France (Not_yet_recruiting)
• Hôpital Cochin — Paris, France (Not_yet_recruiting)
• Hôpital Saint Antoine — Paris, France (Recruiting)
• Hôpital Haut Lévêque CHU Bordeaux — Pessac, France (Recruiting)
• CHU Poitiers — Poitiers, France (Recruiting)
• CHU Toulouse — Toulouse, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Anna PELLAT — Saint-Antoine Hospital
• Study coordinator: Anna PELLAT, MD

Conditions Neuroendocrine Carcinoma; Digestive Cancer; Neoadjuvant treatment; Adjuvant treatment