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Study on the Effectiveness of Oxaliplatin, Docetaxel, and Fluorouracil in Patients with Resectable Gastric and Gastroesophageal Junction Cancer

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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 a type of cancer called gastric and gastroesophageal junction adenocarcinoma, which affects the stomach and the area where the stomach meets the esophagus. The study is investigating a treatment approach that combines a special procedure called HIPEC (Hyperthermic Intraperitoneal Chemotherapy) with a chemotherapy regimen known as FLOT. FLOT is a combination of four drugs: oxaliplatin, docetaxel, fluorouracil, and calcium folinate. The trial aims to compare the effectiveness of using HIPEC with FLOT against using FLOT alone in patients who have a resectable form of this cancer, meaning the cancer can be surgically removed.

The purpose of the study is to see if adding HIPEC to the FLOT treatment can improve the time patients live without the cancer coming back or getting worse, which is known as progression-free survival. Participants in the study will receive either the combination of HIPEC and FLOT or just FLOT alone. The treatment will be given over a period of time, and patients will be monitored to see how well they respond to the treatment and how it affects their quality of life. The study will also look at the overall survival of patients, which is the time from the start of the study until death from any cause.

Throughout the study, patients will undergo regular assessments to check the status of their cancer and their overall health. These assessments may include imaging tests like MRI or CT scans to look for any signs of cancer progression. The study will also track any side effects or complications that may arise from the treatment. The goal is to gather information that could help improve treatment strategies for this type of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide written consent, confirming your willingness to participate and comply with the study protocol.
You will undergo a series of initial assessments to confirm eligibility, including a review of your medical history and current health status.
Step 2
Pre-treatment phase
You will receive 3 to 6 cycles of a chemotherapy regimen called FLOT, which includes the medications fluorouracil, leucovorin (also known as calcium folinate), oxaliplatin, and docetaxel. These medications are administered through a vein (intravenous use).
The specific dosage and frequency will be determined by your healthcare provider based on your individual health needs.
Step 3
Surgery and treatment
After completing the pre-treatment phase, you will undergo surgery to remove the tumor.
Depending on the study group you are assigned to, you may receive an additional treatment called HIPEC (Hyperthermic Intraperitoneal Chemotherapy) with cisplatin, which involves administering heated chemotherapy directly into the abdominal cavity.
Step 4
Post-treatment monitoring
Following surgery and any additional treatments, you will be monitored regularly to assess your recovery and check for any signs of disease progression or recurrence.
This monitoring will include regular medical check-ups, imaging tests, and laboratory assessments as determined by your healthcare team.
Step 5
Long-term follow-up
You will continue to be followed up for several years to evaluate your overall survival and quality of life.
This phase includes periodic assessments to monitor your health status and any long-term effects of the treatment.

Who can join the trial?

10 criteria

The patient must have a type of stomach cancer called resectable diffuse or mixed type adenocarcinoma of the gastroesophageal junction or the stomach.
The patient must be able and willing to provide written consent and follow the study rules and planned surgeries.
The patient must have received 3 to 6 cycles of a specific chemotherapy treatment called neoadjuvant FLOT.
The patient must not have had any other cancer treatments before, except for the neoadjuvant FLOT.
The patient must not have had any part of the tumor removed before.
The patient must be between 18 and 75 years old. Female patients who can have children must have a negative pregnancy test before starting the study. Both male and female patients must agree to use effective birth control methods during the study.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must not have cancer that has spread to distant parts of the body, confirmed by scans like CT or MRI.
The patient must not have cancer that has spread to the lining of the abdomen, confirmed by a procedure called laparoscopy before starting FLOT chemotherapy.
The patient must have blood, liver, and kidney function levels that are good enough for surgery and a treatment called HIPEC, as decided by the study doctor.

Who cannot join the trial?

4 criteria

Patients with a type of stomach cancer called **diffuse type gastric adenocarcinoma** or cancer at the junction of the stomach and esophagus (gastroesophageal junction) cannot participate if it is not **resectable**. This means the cancer cannot be removed by surgery.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
Patients who are part of a **vulnerable population** may not be eligible. This term refers to groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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

Verified
Goethe University Frankfurt
Frankfurt, Germany
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany
Verified
Kliniken der Stadt Koeln gGmbH
Cologne, Germany

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Investigated drugs

FLOT
is a combination of four different chemotherapy drugs used together to treat certain types of cancer, including gastric and gastroesophageal junction adenocarcinoma. This combination includes drugs that work together to stop cancer cells from growing and dividing. The goal of using FLOT is to shrink the tumor before surgery and to help prevent the cancer from coming back after surgery.
HIPEC
, which stands for Hyperthermic Intraperitoneal Chemotherapy, is a special treatment used during surgery for certain types of cancer. After the surgeon removes visible tumors, a heated chemotherapy solution is circulated in the abdominal cavity. The heat helps the chemotherapy work better by allowing it to penetrate deeper into tissues and kill any remaining cancer cells. This treatment aims to reduce the risk of cancer returning.

What is already known about the treatment

Preventive HIPEC – Preventive HIPEC is a treatment administered directly into the abdominal cavity, typically during surgery, to target cancer cells in patients with resectable diffuse type gastric and gastroesophageal junction adenocarcinoma. It is currently being studied in clinical trials to determine its effectiveness in improving progression-free and disease-free survival compared to standard chemotherapy alone. The main therapeutic indication is for patients with specific types of stomach and gastroesophageal cancers. At the molecular level, HIPEC works by delivering heated chemotherapy directly to the cancer site, which may enhance the drug's ability to kill cancer cells. It is classified as a localized chemotherapy treatment.

Investigated diseases

Resectable diffuse type gastric and gastroesophageal junction Type II/III adenocarcinoma – This disease is a form of cancer that originates in the glandular cells lining the stomach and the area where the stomach meets the esophagus. It is characterized by a diffuse spread of cancer cells, which infiltrate the stomach wall and can make the stomach rigid. The progression involves the cancer cells spreading through the stomach lining and potentially to nearby lymph nodes and other organs. As the disease advances, it can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain. The diffuse type is known for its tendency to spread more widely and deeply compared to other types of gastric cancer. This type of adenocarcinoma is often diagnosed at a more advanced stage due to its subtle early symptoms.