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

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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 known as localized digestive neuroendocrine carcinomas. These are rare tumors that occur in the digestive system and are characterized by their ability to produce hormones. The study aims to evaluate the effectiveness of a 12-month treatment plan using neoadjuvant chemotherapy, which is chemotherapy given before surgery to shrink the tumor. The main goal is to see if this treatment can improve the time patients remain free from cancer after treatment, known as disease-free survival.

The treatment involves the use of three chemotherapy drugs: etoposide, carboplatin, and cisplatin. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will monitor patients over a period of 12 months to assess how well the treatment works in preventing the cancer from returning or spreading. Additionally, the study will collect information on any side effects experienced by patients during the treatment.

Throughout the study, various tests and analyses will be conducted to understand the response of the cancer to the treatment. This includes looking at specific markers in the cancer cells and analyzing genetic information to see if certain characteristics of the cancer can predict how well the treatment will work. The study will also evaluate the overall survival of patients and the feasibility of the treatment regimens. The information gathered from this study will help in understanding the potential benefits of using these chemotherapy drugs in treating localized digestive neuroendocrine carcinomas.

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.

    The chemotherapy involves three medications: etoposide, carboplatin, and cisplatin. These are given through a vein, a method known as intravenous use.

  2. Step 2

    Chemotherapy regimen

    The chemotherapy is administered over a period of 12 months.

    The specific dosage and frequency of each medication will be determined by the healthcare provider based on individual patient needs and response to treatment.

  3. Step 3

    Monitoring and assessment

    Regular assessments are conducted to monitor the response to the chemotherapy. This includes imaging tests like CT scans and PET scans to evaluate the tumor's size and spread.

    Blood tests and other evaluations are performed to check for any side effects and to ensure the treatment is working effectively.

  4. Step 4

    Surgical consultation

    A multidisciplinary team reviews the patient's progress to determine if the tumor is resectable, meaning it can be surgically removed.

    The decision for surgery is based on the tumor's response to chemotherapy and the overall health of the patient.

  5. Step 5

    Surgery

    If the tumor is deemed resectable, surgery is performed to remove it.

    The timing and specifics of the surgery are planned based on the patient's condition and the tumor's characteristics.

  6. Step 6

    Post-treatment follow-up

    After surgery, follow-up appointments are scheduled to monitor recovery and check for any signs of cancer recurrence.

    Additional treatments may be recommended based on the surgical findings and the patient's recovery.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of **digestive neuroendocrine carcinoma (CNE)**, which is a type of cancer affecting the digestive system. This must be confirmed through a biopsy, a procedure where a small sample of tissue is taken for examination.
  • The cancer must be **localized**, meaning it has not spread to other parts of the body. This is confirmed through imaging tests like a **CT scan** (a detailed X-ray) and a **thoraco-abdominopelvic CT scan** (a scan of the chest, abdomen, and pelvis).
  • A **PET scan** (a type of imaging test) and a CT scan must be done to check the status of the lymph nodes and to ensure there are no secondary issues in other organs or bones.
  • The tumor must be **resectable**, meaning it can be surgically removed. This decision is made by a team of doctors during a special meeting.
  • The patient must be **18 years or older**.
  • For women who can have children, a **negative pregnancy test** is required 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?

3 criteria

  • Patients with medical conditions other than **localized digestive Neuroendocrine Carcinomas** cannot participate. This means the study is only for those with a specific type of cancer in the digestive system.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups, but the exact ages are not specified here.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.
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Investigated drugs

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

What is already known about the treatment

Neoadjuvant Chemotherapy – This treatment is administered intravenously, allowing the medication to enter the bloodstream directly. It is currently being studied in clinical trials, specifically in a Phase II study, to assess its effectiveness in improving disease-free survival in patients with localized digestive neuroendocrine carcinomas. The main therapeutic indication is to reduce the risk of cancer recurrence after surgical removal of the tumor. At the molecular level, chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and replication. It is classified pharmacologically as an antineoplastic agent, which is a type of medication used to treat cancer.

Investigated diseases

Localized Digestive Neuroendocrine Carcinomas – This disease involves tumors that originate in the neuroendocrine cells of the digestive system. These cells have traits of both nerve cells and hormone-producing cells. The tumors are typically found in the stomach, intestines, or pancreas. They are considered localized when they have not spread to other parts of the body. The progression of the disease can vary, with some tumors growing slowly while others may grow more rapidly. Symptoms often depend on the location of the tumor and may include abdominal pain, changes in bowel habits, or hormonal imbalances.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515603-19-01Protocol codeNEONEC D19-01Estimated enrolment78 patientsSponsorAssociation Gercor

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).