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

Launched by GERCOR - MULTIDISCIPLINARY ONCOLOGY COOPERATIVE GROUP · Feb 11, 2020

Keywords

ClinConnect Summary

This clinical trial, called NEONEC, is studying the effectiveness of a specific type of chemotherapy given before surgery for patients with localized neuroendocrine carcinoma (NEC), a type of digestive cancer. The goal of the trial is to see if this treatment can help patients live longer without their cancer coming back after treatment (this is known as relapse-free survival). The chemotherapy being used combines two drugs: platinum (either cisplatin or carboplatin) and etoposide. For patients with tumors located in the anorectal area, a combination of chemotherapy and radiation therapy will be used to reduce the need for more invasive surgeries.

To participate in this study, patients should be at least 18 years old and have been diagnosed with localized, poorly differentiated NEC that has not spread to other parts of the body. Participants will need to provide written consent and be registered in a national health system. Throughout the study, patients may undergo various tests to monitor their health and the effectiveness of the treatment. It's important to note that those with certain health conditions, such as organ failure or well-differentiated NEC, will not be eligible for this trial. If you or a loved one are interested in participating, please consult with a healthcare provider for more information.

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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 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.