This clinical trial is focused on studying a type of cancer known as metastatic grade 3 poorly differentiated neuroendocrine carcinoma, which affects the digestive system and sometimes has an unknown origin. The study aims to compare two different chemotherapy treatments to see which one is more effective in managing this cancer. The first treatment is called mFOLFIRINOX, which is a combination of several drugs, including irinotecan hydrochloride trihydrate and fluorouracil. The second treatment involves a combination of platinum drugs, such as cisplatin and oxaliplatin, along with etoposide.
The purpose of the study is to determine which treatment helps patients live longer without the cancer getting worse. Participants will receive one of the two treatments, and their progress will be monitored over time. The study will also involve regular assessments using imaging techniques like CT scans or MRI to measure the size of the cancer and see how it responds to the treatment. Additionally, the study will look at the overall survival of patients and any side effects they may experience from the treatments.
Throughout the study, researchers will also collect information about the cancer’s genetic makeup to identify potential targets for future therapies. This information will help doctors understand how different genetic changes in the cancer might affect the response to treatment. The study is expected to continue until 2029, providing valuable insights into the best treatment options for this challenging type of cancer.
1initial assessment
Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, current health status, and ensuring all inclusion criteria are met.
A physical examination and necessary laboratory tests are performed to establish a baseline for health parameters.
2treatment plan discussion
The treatment plan is explained, including the two possible chemotherapy regimens: mFOLFIRINOX and platinum-etoposide. The choice of regimen is determined by the study protocol.
Potential side effects and the expected duration of treatment are discussed to ensure understanding and consent.
3chemotherapy administration
Chemotherapy is administered through an intravenous infusion. The specific drugs used include cisplatin, oxaliplatin, irinotecan hydrochloride trihydrate, fluorouracil, and etoposide.
The frequency and dosage depend on the assigned regimen. Each cycle of treatment is followed by a rest period to allow the body to recover.
4regular monitoring
Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests, imaging studies, and physical examinations.
Adjustments to the treatment plan may be made based on the results of these assessments.
5follow-up assessments
Follow-up assessments are scheduled to evaluate the effectiveness of the treatment and to monitor for any long-term effects.
These assessments help determine progression-free survival and overall response to the treatment.
6end of trial
At the end of the trial, a final evaluation is conducted to summarize the outcomes and any changes in health status.
Participants are provided with information on further care and any additional follow-up that may be necessary.
Who Can Join the Study?
Must have a type of cancer called Grade 3 neuroendocrine carcinoma or a similar high-grade cancer.
Blood tests must show total bilirubin levels at or below 1.5 times the normal limit, and AST and ALT levels at or below 2.5 times the normal limit, or 5 times if there is cancer in the liver.
Must be at least 18 years old.
Must have signed a consent form agreeing to participate and follow the study rules.
If a woman can have children, or if a man has relations with such a woman, they must use effective birth control during the study and for 6 months after the last dose of the study drug.
Must be covered by the Social Security system.
Cancer must originate from the gastro-entero-pancreatic area or be of unknown origin.
Must have a type of cancer called neuroendocrine carcinoma, which can be small cell, large cell, non-small cell, or not easily classified.
Cancer must have spread to other parts of the body (metastatic disease).
Must have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
This must be the first treatment for metastatic disease, with no prior chemotherapy or systemic therapy for the cancer.
Must have at least one measurable tumor as seen on a CT scan or MRI.
Must have a tumor sample available for testing.
Blood tests must show ANC (a type of white blood cell) at or above 1.5×109/l, platelets at or above 100×109/l, and hemoglobin above 8 g/dl.
Who Cannot Join the Study?
Patients with other types of cancer that are not the specific type being studied.
Patients who have had another cancer treatment within a certain time frame before the study starts.
Patients with serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.
Patients who have allergies to the medications used in the study.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients with certain infections that could affect the study results.
Patients who are not able to give informed consent, which means they cannot understand the study and agree to participate.
FOLFIRINOX is a combination of four different chemotherapy drugs used together to treat certain types of cancer. This therapy is designed to attack cancer cells in multiple ways, making it harder for the cancer to grow and spread. Patients receive these medications through an IV, which allows the drugs to enter the bloodstream and reach cancer cells throughout the body.
Platinum refers to a group of chemotherapy drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. This type of treatment is often used for various cancers and is administered through an IV.
Etoposide is a chemotherapy medication that helps stop cancer cells from dividing and growing. It works by interfering with the DNA of the cancer cells, which can lead to their death. Etoposide is usually given through an IV, allowing it to circulate in the bloodstream and target cancer cells throughout the body.
Metastatic Grade 3 Poorly Differentiated Neuroendocrine Carcinoma of Gastroenteropancreatic and Unknown Primary – This is a type of cancer that originates from neuroendocrine cells, which are found throughout the body, particularly in the gastrointestinal tract and pancreas. It is characterized by poorly differentiated cells, meaning the cancer cells look very different from normal cells and tend to grow and spread more aggressively. The term “metastatic” indicates that the cancer has spread from its original site to other parts of the body. The progression of this disease involves rapid growth and dissemination to distant organs, often making it challenging to determine the primary site of origin. As the disease advances, it can lead to various symptoms depending on the organs affected by the metastases. The aggressive nature of this carcinoma often results in significant changes in the affected tissues and organs.
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