Not recruiting

Study on Liposomal Irinotecan, Carboplatin, or Oxaliplatin for First-Line Treatment in Patients with Advanced Esophagogastric Cancer

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 treatments for a type of cancer known as esophagogastric cancer, which affects the esophagus and stomach. The study is specifically for patients whose cancer has spread or cannot be removed by surgery and who have not received prior treatment for this condition. The trial will explore the effectiveness of different medications, including Xeloda (capecitabine), Onivyde (irinotecan), Carboplatin, Oxaliplatin, and Fluorouracil. These medications are used in various combinations to see which works best in controlling the cancer and managing side effects.

The purpose of the study is to compare how long patients can live without their cancer getting worse, known as progression-free survival, and to assess the side effects, particularly nerve damage, of the treatments. Patients will receive one of the treatment combinations, which may include a placebo, and their health will be monitored over time. The study will also look at the overall survival of patients, their quality of life, and how they respond to the treatments according to specific medical guidelines.

Participants in the study will receive treatment through different methods, such as oral tablets or intravenous infusions, which means the medication is given directly into a vein. The study will last for several months, and patients will have regular check-ups to monitor their progress and any side effects. The goal is to find the most effective treatment plan for patients with esophagogastric cancer, improving their chances of living longer and with a better quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, you will start the treatment for esophagogastric cancer. This involves taking medications that are part of the study.
The treatment includes different medications, which are administered in specific ways and at certain times.
Step 2
Medication administration
You will take Xeloda 500 mg film-coated tablets orally. The dosage and frequency will be determined by the study team.
You will receive Onivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion through an intravenous infusion. This means the medication will be given directly into your vein.
You will also receive Carboplatin 10 mg/ml intravenous infusion, Oxaliplatin 5mg/ml concentrate for solution for infusion, and Fluorouracil 50mg/ml injection through intravenous administration. The study team will provide specific instructions on the dosage and schedule.
Step 3
Monitoring and follow-up
Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to assess the progression of the disease and any side effects.
The main goal is to evaluate the time from the start of the treatment until the disease progresses and to monitor any side effects related to the nervous system.
Step 4
End of treatment
The study will continue until a specified end date or until the disease progresses. The study team will inform you about the duration of your participation.
After the treatment ends, there may be additional follow-up to assess your overall health and any long-term effects of the treatment.

Who can join the trial?

13 criteria

Patients must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
If a female patient can have children, she must have a negative pregnancy test before starting the study treatment. If she is sexually active, she must agree to use birth control during the study and for a period after the study ends.
Patients should not have any psychological, family, social, or geographical issues that might prevent them from following the study rules and schedule.
Patients must be adults, meaning they are 18 years or older.
Patients must have a confirmed diagnosis of metastatic or irresectable (cannot be removed by surgery) adenocarcinoma of the stomach or esophagus that is HER2 negative. If they have HER2 positive disease, they can participate if they cannot be treated with trastuzumab. If a tissue sample cannot be obtained, a cell sample is acceptable to confirm metastatic disease.
Patients must not have received systemic therapy (treatment affecting the whole body) for their irresectable or metastatic disease. Palliative radiotherapy (treatment to relieve symptoms) on the primary tumor or a metastatic lesion is allowed if there are other untreated lesions that can be evaluated.
Patients must have measurable disease, which means the cancer can be measured using specific criteria called RECIST 1.1.
Patients must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a patient can perform daily activities.
Patients must have adequate bone marrow and organ function, as shown by specific blood test results:
- Absolute Neutrophil Count (ANC) greater than 1.5 x 10⁹/L
- Hemoglobin (Hgb) greater than 5.6 mmol/L
- Platelets greater than 100 x 10⁹/L
- Serum total bilirubin must be within 1.5 times the upper limit of normal (ULN), or less than 3.0 times ULN with direct bilirubin within normal range for patients with well-documented Gilbert's syndrome. Biliary drainage is allowed for bile duct obstruction.
- Serum creatinine must be less than 1.5 times ULN or creatinine clearance greater than 30 mL/min/1.73 m². Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be less than 2.5 times ULN or less than 5.0 times ULN if liver metastases are present.

Who cannot join the trial?

10 criteria

Patients who have already received treatment for their esophagogastric cancer cannot participate.
Patients with other types of cancer that are not esophagogastric cancer are not eligible.
Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or comply with the study requirements are not eligible.
Patients with known allergies to the study medications or their ingredients cannot participate.
Patients who are participating in another clinical trial at the same time are excluded.
Patients with a history of severe allergic reactions to similar drugs are not eligible.
Patients with certain heart conditions that could be worsened by the study treatment are excluded.
Patients with active infections that require treatment are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Liposomal Irinotecan
is a form of chemotherapy that is used to treat cancer. It works by stopping the growth of cancer cells. In this trial, it is being tested to see how well it works as a first treatment for esophagogastric cancer. The medication is delivered in a special way, using tiny fat-like particles called liposomes, which help the drug stay in the body longer and target the cancer cells more effectively.
Carboplatin
is another chemotherapy drug used in this trial. It helps to kill cancer cells by damaging their DNA, which stops them from growing and dividing. Carboplatin is often used to treat various types of cancer and is being tested here to see how effective it is in treating esophagogastric cancer when used as a first treatment option.
Oxaliplatin
is also a chemotherapy medication included in this study. It works similarly to Carboplatin by interfering with the DNA of cancer cells, preventing them from multiplying. This drug is being evaluated in the trial to determine its effectiveness in treating esophagogastric cancer as a first-line treatment.

What is already known about the treatment

Liposomal Irinotecan – This medication is administered intravenously, meaning it is given through a vein, and is used in the treatment of esophagogastric cancer that has not been treated before and has spread or is locally advanced. It is currently being studied in clinical trials to assess its effectiveness and side effects, particularly focusing on how long it can prevent cancer from getting worse and its impact on nerve health. Liposomal Irinotecan works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. It belongs to a class of drugs known as topoisomerase inhibitors, which are used to treat various types of cancer.

Investigated diseases

Esophagogastric Cancer – Esophagogastric cancer refers to malignant tumors that occur in the esophagus and stomach. This type of cancer often begins in the cells lining the esophagus or stomach and can spread to nearby tissues and organs. As the disease progresses, it may cause symptoms such as difficulty swallowing, weight loss, and abdominal pain. The cancer can invade deeper layers of the esophagus or stomach and may spread to lymph nodes and other parts of the body. Over time, the tumor can grow larger and affect the function of the digestive system. The progression of esophagogastric cancer can vary depending on the specific location and type of cancer cells involved.