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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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital Beaujon Clichy France
Hospital Edouard Herriot Lyon France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
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Ioizysej Pfrglswqygwadgr Ctanmz Cgopur Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
06.01.2020

Trial locations

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.

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 ID:
2024-515603-19-01
Protocol code:
NEONEC D19-01
NCT ID:
NCT04268121
Trial Phase:
Therapeutic exploratory (Phase II)

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