Recruiting

A study of irinotecan and a drug combination for patients with gastric cancer or gastroesophageal junction cancer undergoing surgery.

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 study focuses on individuals with gastric cancer, which is cancer of the stomach, or gastroesophageal junction cancer, which is cancer located where the esophagus meets the stomach. The purpose of the study is to find the best dose and safety of a combination treatment. This treatment involves using irinotecan, a chemotherapy drug, through a method called intraperitoneal administration, which means the medication is delivered directly into the abdominal cavity. This will be used alongside a systemic treatment regimen known as FLOT, which is a combination of four different drugs delivered through the bloodstream.

Participants in this study will undergo a gastrectomy, a surgical procedure to remove part or all of the stomach. Around the time of the surgery, the medication will be administered to target the cancer cells. The study will monitor how the body processes the drugs and look for any side effects or complications that may occur during or after the treatment process.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Preoperative treatment
Treatment begins with chemotherapy, which is medicine used to kill cancer cells.
The medication FLOT is administered through the bloodstream (systemic) as part of the treatment plan before surgery.
Step 2
Surgery
A gastrectomy, which is the surgical removal of part or all of the stomach, is performed.
Step 3
Intraperitoneal treatment
After surgery, irinotecan is administered directly into the peritoneal cavity, which is the space in the abdomen that holds the stomach and other organs.
The dosage of irinotecan is 75 mg.
This medicine is provided as a solution for infusion, meaning it is delivered through a tube into the abdominal space.

Who can join the trial?

7 criteria

You must have a confirmed diagnosis of adenocarcinoma, which is a type of cancer that starts in the glands of the stomach or the area where the esophagus meets the stomach.
You must be scheduled to undergo a gastrectomy, which is a surgical procedure to remove part or all of your stomach.
You must be planning to receive perioperative FLOT chemotherapy, which means receiving a specific combination of drugs before and after your surgery.
You must have a WHO performance score of 0 or 1, which is a scale used by doctors to measure how well you can carry out daily activities and your overall physical health.
You must have a life expectancy of at least three months.
You must be 18 years of age or older.
You must provide written informed consent, which means you have read and signed a document agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

12 criteria

Having any medical reason that prevents you from receiving systemic chemotherapy, which is medicine used to treat cancer that travels through your entire body. This includes having an active infection, a serious disease happening at the same time, or a severe allergy.
Experiencing lasting neurologic toxicity, which means long-term nerve damage or problems with the nervous system, following previous treatments with oxaliplatin based therapy.
Having inadequate organ function, which means your organs are not working well enough. This includes:
Low hemoglobin levels, which is a protein in your red blood cells that carries oxygen.
A low absolute neutrophil count, which refers to a low number of white blood cells that help your body fight infections.
A low platelet count, which means you do not have enough blood cells to help your blood clot.
Low creatinine clearance, which is a measure of how well your kidneys are filtering waste from your blood.
High bilirubin levels, which is a yellow substance produced when red blood cells break down, indicating possible liver issues.
High liver transaminases, which are enzymes in your blood that can indicate your liver is stressed or damaged.
Being pregnant or lactating (breastfeeding).
Taking part in another clinical study at the same time that might change the results of this study.
Being unable or unwilling to follow the study protocol, which is the specific set of rules and steps required for this medical research.

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Verified sites

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

Catharina Ziekenhuis Stichting
Verified
Eindhoven, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Irinotecan
is a type of chemotherapy medicine that is delivered directly into the abdominal cavity through a small tube or needle to help treat cancer cells in that area.
FLOT
is a combination of four different chemotherapy drugs given through a vein to treat cancer cells that may be throughout the body.

Irinotecan Hydrochloride Trihydrate

What is already known about the treatment

Irinotecan hydrochloride trihydrate - This medication is an anticancer drug administered as a liquid solution through an infusion directly into the abdominal cavity. It is a well-established treatment used primarily to manage certain types of cancer, including those found in the digestive system. It works by blocking an enzyme that cancer cells need to copy their DNA, which prevents the cells from growing and multiplying. This drug belongs to a group of medicines known as topoisomerase inhibitors.

Investigated diseases

Gastric cancer - This disease involves the uncontrolled growth of abnormal cells within the stomach. It typically begins in the lining of the stomach and can spread to deeper layers of the organ. As the condition progresses, these cells may grow into a tumor and potentially invade nearby tissues. It can also travel through the blood or lymphatic system to other parts of the body.