Not recruiting

Study of hyperthermic intraperitoneal chemotherapy with oxaliplatin, fluorouracil, and calcium levofolinate in patients with advanced gastric cancer after 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 patients with gastric adenocarcinoma, which is a type of stomach cancer that develops in the glandular cells lining the stomach. The purpose is to compare survival rates between two different treatment approaches for advanced stomach cancer. The study examines whether adding a special treatment called Hyperthermic Intraperitoneal Chemotherapy (HIPEC) after surgery improves outcomes compared to surgery alone.

The treatment involves surgical removal of the stomach (gastrectomy) followed by HIPEC in one group of patients. HIPEC is a procedure where heated chemotherapy drugs are circulated directly in the abdominal cavity. The medications used during HIPEC include oxaliplatin, fluorouracil, and calcium levofolinate. These drugs are administered through the veins or directly into the abdominal cavity during the procedure.

The study will monitor patients' overall survival, cancer recurrence, side effects, and quality of life. Half of the patients will receive surgery with HIPEC, while the other half will receive surgery alone. The treatment approach each patient receives is determined randomly, similar to flipping a coin.

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
Initial treatment group assignment
You will be randomly assigned to one of two treatment groups: group A (surgery with additional heated chemotherapy) or group B (surgery only)
Both groups will undergo a gastrectomy (surgical removal of part or all of the stomach)
Step 2
Surgical procedure
You will undergo a D2 resection (surgical removal of stomach cancer)
This procedure is performed to remove the cancer and affected lymph nodes
Step 3
Additional treatment for Group A
If you are in group A, you will receive HIPEC (Heated chemotherapy) during the surgery
The HIPEC procedure uses three medications: calcium levofolinate, fluorouracil, and oxaliplatin
These medications will be administered through your veins and directly into the abdominal cavity
The chemotherapy solution will be heated and circulated in your abdominal cavity during the procedure
Step 4
Follow-up period
Your recovery and health status will be monitored for up to 5 years
Regular check-ups will track your overall survival and recovery
Medical staff will monitor for any signs of cancer recurrence
Your quality of life will be evaluated throughout the follow-up period
Step 5
Safety monitoring
Throughout the study, you will be monitored for any side effects or complications
Regular health assessments will include blood tests and medical examinations
Any treatment-related issues will be documented and addressed by the medical team

Who can join the trial?

11 criteria

Age between 18 and 75 years old
Confirmed presence of gastric adenocarcinoma (stomach cancer) that can be surgically removed, with specific characteristics: - Cancer that has grown into the outer layer of the stomach, or - Cancer that has spread to lymph nodes, or - Presence of cancer cells in the abdominal cavity fluid
For women who can become pregnant and men with partners who can become pregnant: Must use effective birth control methods: - Women: For 4 months after treatment with Oxaliplatin (chemotherapy drug) - Men: For 6 months after treatment with Oxaliplatin
Blood test results showing: - White blood cells above 3,500 per cubic millimeter - Neutrophils (type of white blood cells) at least 1,500 per cubic millimeter - Platelets at least 100,000 per cubic millimeter
Good kidney function with: - Blood creatinine less than 1.5 mg/dl - Creatinine clearance greater than 60 ml/min
Good overall physical condition (Performance Status score of 1 or better, Karnofsky Index 70% or higher)
Liver function test showing bilirubin level of 2 mg/dl or less
Must provide written informed consent
Must have health insurance coverage where applicable
Must not be under any legal or administrative supervision
Must have one of these conditions: - Gastric adenocarcinoma - Perforated gastric adenocarcinoma - Type III Siewert adenocarcinoma of the cardia (cancer at the junction of stomach and esophagus)

Who cannot join the trial?

15 criteria

Age less than 18 years or over 75 years
Previous cancer treatments (chemotherapy, radiotherapy, or surgery) for stomach cancer
Presence of distant metastases (cancer spread to distant organs)
Severe heart conditions that make surgery risky
Severe lung disease that makes surgery risky
Severe liver disease or kidney failure
Pregnancy or breastfeeding
Active infection that requires treatment
Peritoneal carcinomatosis (cancer spread throughout the abdominal cavity)
Unable to understand and sign informed consent
Participation in another clinical trial within the last 30 days
Mental conditions that prevent following study procedures
Known allergies to medications used in the study
Body Mass Index (BMI) greater than 35 (severe obesity)
Unstable medical conditions that could interfere with study participation

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Hyperthermic IntraPeritoneal Chemoperfusion (HIPEC)
is a treatment that combines heat with chemotherapy drugs. During this procedure, heated chemotherapy medication is circulated throughout the abdominal cavity after surgery. This treatment is designed to target any remaining cancer cells directly. The heated chemotherapy solution is administered while the patient is still in surgery, immediately after the tumor has been removed. The heat from this treatment helps the chemotherapy penetrate tumor cells better while also directly killing some cancer cells.
Standard Gastrectomy
is a surgical procedure that involves removing all or part of the stomach to treat gastric cancer. This is the conventional surgical approach for treating advanced stomach cancer, where the surgeon removes the affected part of the stomach along with surrounding lymph nodes to remove the cancer.

What is already known about the treatment

Based on the provided clinical trial data, the trial involves Hyperthermic Intraperitoneal Chemotherapy (HIPEC), but specific medications are not mentioned in the source data. Therefore, I can only provide a general description of HIPEC as a treatment method: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - A specialized treatment procedure where heated chemotherapy drugs are circulated throughout the abdominal cavity during surgery, administered directly after surgical removal of visible tumors. This treatment method combines the effects of high temperature with chemotherapy to target potential remaining cancer cells in patients with gastric adenocarcinoma. HIPEC is classified as a local-regional cancer treatment approach that delivers concentrated chemotherapy directly to the abdominal cavity while minimizing exposure to the rest of the body. The heating of the chemotherapy solution to temperatures above normal body temperature helps to enhance the effectiveness of the drugs and their penetration into tissues.

Investigated diseases

Gastric adenocarcinoma - A type of cancer that develops in the glandular cells of the stomach lining. It begins when cells in the stomach start to grow out of control and form a tumor. The cancer typically develops slowly over many years, starting with pre-cancerous changes in the stomach's inner lining. As it grows, it can spread deeper into the stomach wall and potentially to other parts of the body. This cancer can affect how the stomach works, including its ability to hold food and produce digestive juices. It can cause changes in appetite and digestion as it progresses.