Study of hyperthermic intraperitoneal chemotherapy with oxaliplatin, fluorouracil, and calcium levofolinate in patients with advanced gastric cancer after surgery

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What is this study about?

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.

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)

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Iwapbcjh Rozwhhoc De Crgymo Dz Mbhtqvlylzi	Montpellier	France
Cpvpym Lwkl Bjcyng	Lyon	France
Adqldrewnt Pyocxlpx Hlshauqy Du Mxyrbnmqk	Marseille	France
Hctxczyt Uqlxprxnylvctu Sptggpwjps &ljcabs Hdxuqlw dn Hkdqpdbrchk	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.08.2024

Trial locations

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.

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.

Trial ID:

2024-516358-23-00

Protocol code:

2012-761

NCT ID:

NCT01882933

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of hyperthermic intraperitoneal chemotherapy with oxaliplatin, fluorouracil, and calcium levofolinate in patients with advanced gastric cancer after surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?