Not recruiting

Study on Irinotecan, Fluorouracil, Oxaliplatin, and Calcium Folinate for Patients with Resectable Stomach and Gastroesophageal Junction 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 the treatment of resectable gastric and gastroesophageal junction adenocarcinoma, which are types of cancer that occur in the stomach and the area where the stomach meets the esophagus. The treatment being tested is a combination of medications known as FOLFOXIRI, which includes fluorouracil, oxaliplatin, calcium folinate, and irinotecan hydrochloride trihydrate. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how well this combination of medications works in treating the cancer before and after surgery. Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study aims to determine the rate of response to the treatment according to specific criteria, as well as to assess the safety and potential side effects of the treatment.

Throughout the study, participants will be closely monitored for any changes in their condition, and the effectiveness of the treatment will be evaluated at various points. The study will also look at the rate of successful surgical removal of the cancer and track the participants' health over several years to understand the long-term effects of the treatment. This research is part of a larger effort to improve treatment options for patients with these types of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the treatment begins with the administration of a combination of medications. These medications include fluorouracil, oxaliplatin, calcium folinate, and irinotecan hydrochloride trihydrate.
All medications are given through an intravenous route, which means they are administered directly into a vein.
Step 2
Perioperative treatment phase
The treatment is part of a perioperative phase, which involves administering the medications before and after surgery to treat gastric and gastroesophageal junction adenocarcinoma.
The goal is to assess the response of the cancer to the treatment using specific criteria.
Step 3
Surgery
Surgery is performed to remove the cancerous tissue. The timing of the surgery is determined based on the response to the initial treatment phase.
The effectiveness of the surgery is evaluated within 30 days post-operation.
Step 4
Post-surgery treatment
After surgery, the treatment continues with the same combination of medications to ensure any remaining cancer cells are targeted.
This phase is crucial for improving the chances of a successful outcome.
Step 5
Follow-up and monitoring
Regular follow-up appointments are scheduled to monitor the patient's health and the effectiveness of the treatment.
These follow-ups occur at 12, 18, 24, 30, 36, 48, and 60 months from the start of the trial.
Step 6
Evaluation of treatment outcomes
The primary outcome is the rate of response to the treatment, assessed within 30 days after surgery.
Secondary outcomes include the rate of successful surgery, completion of treatment, survival rates, and monitoring of any side effects or complications.

Who can join the trial?

20 criteria

The patient must have a type of cancer called **gastric or gastroesophageal junction adenocarcinoma** that can be surgically removed.
The patient must be able to follow the study's rules and procedures.
A surgeon must confirm that the patient can have surgery.
The cancer must be at a specific stage, described as **cT2-4a or cN+, cM0**. This means the tumor has grown to a certain size or spread to nearby lymph nodes but not to other parts of the body.
The patient must be **18 years or older**.
The patient must have a **WHO performance status** of 1 or less, which means they are fully active or have some symptoms but can still do light work.
If there is a suspicion of cancer spread to the lining of the abdomen (called **peritoneal carcinomatosis**), it must be ruled out using a procedure called **laparoscopy**.
The patient must have certain **blood test results** within normal limits, including:
- **Hemoglobin** (a protein in red blood cells) must be more than 90 g/L. Blood transfusions are allowed to reach this level.
- **Absolute neutrophil count (ANC)**, a type of white blood cell, must be at least 1.5 x 10⁹/L.
- **Platelets**, which help with blood clotting, must be at least 75 x 10⁹/L.
- **Bilirubin**, a substance made by the liver, must be 1.5 times the upper limit of normal (ULN) or less.
- **ALAT**, a liver enzyme, must be 3 times the ULN or less.
- **Creatinine**, a waste product in the blood, must be 1.5 times the ULN or less.
- Women who can have children and men in relationships with such women must use highly effective birth control methods during the study and for 6 months after. These methods include:
  - Hormonal birth control that stops ovulation, taken by mouth, vaginally, or through the skin.
  - Progestogen-only hormonal birth control that stops ovulation, taken by mouth, by injection, or as an implant.
  - An **intrauterine device (IUD)** or a hormone-releasing system placed in the uterus.
  - **Bilateral tubal occlusion**, a procedure to block the fallopian tubes.
  - A partner who has had a **vasectomy**, a procedure to prevent sperm from being released.
  - Choosing not to have sexual intercourse, if this is the usual and preferred lifestyle of the patient.
  - The patient must sign a document called **informed consent**, which explains the study and confirms their willingness to participate.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have had previous treatment that might interfere with the study results.
Patients with other serious health conditions that could affect their safety during the study.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of substance abuse that could interfere with the study.
Patients who have certain infections that could affect their participation.
Patients who are not able to give informed consent to participate in the study.

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Verified sites

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

Verified
Karolinska University Hospital
Solna, Sweden
Verified
Oslo Universitetssykehus HF
Oslo, Norway
Verified
Region Skane Skanes Universitetssjukhus
Lund, Sweden

Trial locations

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Investigated drugs

Irinotecan
This medication is used in combination with other drugs to treat certain types of cancer. In this trial, it is part of a treatment regimen for gastric and gastroesophageal junction adenocarcinoma. It works by interfering with the growth of cancer cells, which are eventually destroyed.
FOLFOXIRI
This is a combination chemotherapy regimen that includes several drugs, including irinotecan, used to treat cancer. It is designed to attack cancer cells in different ways, making it more effective than using a single drug. In this trial, FOLFOXIRI is used as a perioperative treatment, meaning it is given around the time of surgery to help shrink the tumor and improve surgical outcomes.

What is already known about the treatment

Irinotecan – Irinotecan is administered intravenously, typically as part of a chemotherapy regimen. It is currently used in clinical trials and medical practice for treating certain types of cancer, including gastric and gastroesophageal junction adenocarcinoma. The main therapeutic indication is to treat these cancers, often in combination with other drugs. At the molecular level, irinotecan works by inhibiting an enzyme called topoisomerase I, which is essential for DNA replication in cancer cells, thereby preventing their growth and division. It is classified as a topoisomerase inhibitor in pharmacology.

Investigated diseases

Resectable Gastric and Gastroesophageal Junction Adenocarcinoma – This is a type of cancer that occurs in the stomach or where the stomach meets the esophagus. It is characterized by the growth of malignant cells in the lining of these areas. The disease progresses as the cancer cells invade deeper layers of the stomach or esophageal wall and can spread to nearby lymph nodes or other organs. Early stages may not show symptoms, but as it advances, it can cause difficulty swallowing, weight loss, and stomach pain. The term "resectable" indicates that the tumor can potentially be removed through surgery. The progression and impact of the disease depend on the size and spread of the tumor at the time of diagnosis.