Small intestine carcinoma metastatic Trials in Disease

Study Comparing mFOLFIRINOX and Capecitabine or Gemcitabine for Patients with Resected Ampullary Adenocarcinoma

This clinical trial is being conducted in France and focuses on patients who have had ampullary adenocarcinoma surgically removed. The ampulla of Vater is the area where the bile duct and pancreatic duct join and empty into the small intestine, and cancer in this location can cause symptoms such as jaundice, abdominal pain, and weight loss.

Main inclusion criteria:

• Confirmed diagnosis of ampullary adenocarcinoma that has been surgically removed
• The surgery must have been completed within the last 12 weeks
• The cancer must not have spread to other parts of the body, as confirmed by a CT scan done within 4 weeks before joining
• CA19.9 blood marker level must be less than 180 U/L (this is a substance in the blood that can be elevated in some cancer patients)
• Age 18 years or older

Main exclusion criteria:

• Patients who have not had surgery to remove the cancer
• Inability to take the study medications
• Other serious health conditions that could interfere with treatment
• Pregnancy or breastfeeding
• Participation in another clinical trial at the same time
• History of another type of cancer that has not been successfully treated
• Known allergies to the study medications
• Inability to follow study procedures or attend required visits

Main focus and goal:

The study is investigating which chemotherapy approach is most effective in preventing cancer from returning after surgery. Participants will be randomly assigned to receive either a combination therapy called modified FOLFIRINOX or a single-agent therapy using capecitabine or gemcitabine. The primary goal is to determine which treatment provides the best disease-free survival rate over two years, meaning the time during which the cancer does not return. The study will also assess overall survival rates and quality of life using specific questionnaires. The trial is expected to continue until October 2028.

Investigational drugs:

The trial is testing three different chemotherapy approaches. mFOLFIRINOX is a combination chemotherapy treatment that includes oxaliplatin, irinotecan, fluorouracil, and calcium folinate, administered intravenously. This combination works together to stop the growth of cancer cells by interfering with DNA synthesis and repair. Capecitabine is an oral medication taken as film-coated tablets that is converted in the body to 5-fluorouracil, which prevents cancer cells from growing and dividing. Gemcitabine is administered intravenously and works by incorporating itself into the DNA of cancer cells, leading to cell death. Both capecitabine and gemcitabine are classified as antimetabolites, a type of chemotherapy drug.