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Study on the Effectiveness of Etoposide, Carboplatin, and Cisplatin in Patients with Localized Digestive Neuroendocrine Carcinomas

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called localized digestive neuroendocrine carcinomas. These are rare tumors that occur in the digestive system and are known for their aggressive nature. The study aims to evaluate the effectiveness of a 12-month treatment plan using a combination of chemotherapy drugs. The medications being tested include etoposide, carboplatin, and cisplatin. These drugs are administered through an intravenous infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to see if this treatment can help patients live longer without the cancer coming back. Participants in the study will receive the chemotherapy treatment over a period of 12 months. The study will monitor the patients' health and check for any signs of the cancer returning. The researchers will also look at how well the treatment works before surgery and how patients respond to the chemotherapy. The study will collect information on any side effects experienced by the participants to ensure the treatment is safe and effective.

Throughout the study, various tests and analyses will be conducted to understand the impact of the treatment on the cancer. This includes looking at specific markers in the cancer cells and analyzing genetic information to see how it might affect the response to the treatment. The study will also involve regular check-ups and assessments to track the overall health and survival of the participants. The goal is to gather valuable information that could lead to better treatment options for patients with this type of cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    The treatment begins with the administration of neoadjuvant chemotherapy designed to shrink the tumor before surgery. This involves the use of three medications: etoposide, carboplatin, and cisplatin.

    These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

  2. Step 2

    Chemotherapy regimen

    The chemotherapy regimen is administered over a period of 12 months. The specific schedule and dosage will be determined by the healthcare provider based on individual patient needs and response to treatment.

    The goal of this phase is to improve relapse-free survival, which means preventing the cancer from returning or spreading.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment, regular monitoring and assessments are conducted to evaluate the response to chemotherapy. This includes imaging tests like CT scans and PET scans to check the status of the tumor and any potential spread.

    Blood tests and other evaluations are performed to monitor the body's response to the treatment and to manage any side effects.

  4. Step 4

    Surgical evaluation

    After completing the chemotherapy regimen, the tumor is evaluated for surgical removal. The decision for surgery is based on the tumor's response to the treatment and its resectability, which means whether it can be safely removed.

    A multidisciplinary team of healthcare professionals will review the case to determine the best course of action.

  5. Step 5

    Surgery

    If the tumor is deemed resectable, surgery is performed to remove it. The timing and specifics of the surgery will be planned by the surgical team.

    The objective of the surgery is to achieve complete removal of the tumor and any affected tissues.

  6. Step 6

    Post-treatment follow-up

    After surgery, follow-up care is essential to monitor recovery and to check for any signs of cancer recurrence. This includes regular medical check-ups and imaging tests.

    The healthcare team will also address any side effects from the treatment and provide support for recovery.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of a specific type of cancer called digestive Neuroendocrine Carcinoma (CNE), which is poorly differentiated and has a Ki 67 value greater than 20%. Ki 67 is a measure of how quickly cancer cells are growing.
  • The cancer must be localized, meaning it has not spread to other parts of the body. This is confirmed by a CT scan (a detailed imaging test) done within 21 days before starting the study treatment. There may be involvement of nearby lymph nodes, which are small glands that help fight infection.
  • A Positron Emission Tomography (PET) scan and a CT scan must be done to check the status of lymph nodes and to ensure there are no secondary issues in other organs or bones.
  • The tumor must be considered resectable, meaning it can be surgically removed. This decision is made by a team of medical experts during a meeting.
  • The patient must be at least 18 years old.
  • Female patients who can have children must have a negative pregnancy test within 7 days before starting the study treatment. Both men and women must use reliable birth control during the study and for 6 months after the last treatment.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer that are not localized digestive Neuroendocrine Carcinomas. This means the study is only for a specific type of cancer that affects the digestive system.
  • Patients who have already received treatment for their cancer that is not part of this study. This ensures that the study results are not affected by other treatments.
  • Patients with serious health conditions that could make it unsafe for them to participate. This is to protect the health and safety of the participants.
  • Patients who are unable to follow the study procedures or attend the required visits. This is important to ensure accurate and reliable study results.
  • Patients who are pregnant or breastfeeding. This is to avoid any potential risks to the baby.
  • Patients who are not within the specified age range for the study. The study is designed for a specific age group to ensure the results are applicable to that group.
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Investigated drugs

Neoadjuvant Chemotherapy is a treatment given before the main treatment, which in this trial is surgery. It is used to shrink tumors in patients with localized digestive neuroendocrine carcinomas, making them easier to remove surgically. The goal is to improve the chances of successful surgery and increase the time patients remain free from cancer after treatment.

What is already known about the treatment

Neoadjuvant Chemotherapy – This treatment is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in improving disease-free survival in patients with localized digestive neuroendocrine carcinomas. The main therapeutic indication is to reduce the size of tumors before surgical removal, potentially improving surgical outcomes. At the molecular level, chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and division. It is classified as an antineoplastic agent, which is a type of medication used to treat cancer.

Investigated diseases

Localized Digestive Neuroendocrine Carcinomas – These are rare tumors that originate in the neuroendocrine cells of the digestive system. They are characterized by their ability to produce hormones and can vary widely in their behavior and appearance. Initially, these tumors may grow slowly and remain confined to the digestive tract. Over time, they can become more aggressive and may spread to nearby tissues or organs. Symptoms often depend on the location of the tumor and may include abdominal pain, changes in bowel habits, or hormonal imbalances. The progression of the disease can lead to complications if the tumors grow large or spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515603-19-00Protocol codeNEONEC D19-01Estimated enrolment78 patientsSponsorAssociation Gercor

sourced from the EU Clinical Trials Register and site verification

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