Ongoing Clinical Trials for Small Intestine Adenocarcinoma
There are currently 2 clinical trials investigating treatments for small intestine adenocarcinoma, a rare cancer affecting the small bowel. These studies are taking place in Belgium and France, testing different combinations of chemotherapy drugs both after surgery and for advanced disease.
Clinical trial locations
- Belgium
- France
Study on the Effectiveness of FOLFIRINOX and FOLFOX for Patients with Advanced Small Bowel Cancer Using Calcium Levofolinate, Irinotecan, and Oxaliplatin
This trial, taking place in France, is testing two different chemotherapy combinations for patients with advanced disease that has spread or cannot be removed by surgery. The study compares modified FOLFIRINOX and FOLFOX regimens to determine which works better.
Who can join:
- Patients with confirmed adenocarcinoma of the small intestine that has spread to other parts of the body or has grown into nearby areas and cannot be removed by surgery
- Those who have not received chemotherapy treatment before for this cancer
- Patients with measurable disease according to standard measurement guidelines
- Those under 70 years old with an ECOG status of 2 or less, or over 70 with ECOG status of 0 or 1. ECOG status measures how well you can perform daily activities, with lower numbers meaning better functioning
- Life expectancy of more than 3 months
Who cannot join:
- Patients with other types of cancer besides small bowel adenocarcinoma
- Those who have had another cancer within the last 5 years, except certain skin cancers or very early stage cervical cancer
- Patients with serious heart problems, such as heart failure or recent heart attack
- Those with uncontrolled high blood pressure or active infections requiring antibiotic treatment
- Pregnant or breastfeeding women
- Patients who have participated in another clinical trial within the last 30 days
- Those with known allergies to the study medications
- Patients with severe liver or kidney disease or a history of drug or alcohol abuse within the last year
What the trial tests: The study evaluates whether modified FOLFIRINOX or FOLFOX chemotherapy regimens can help patients live longer without their cancer getting worse. The main goal is to assess how many patients are alive without disease progression at 8 months. The trial will also track overall survival rates and how long patients live without their cancer progressing. All medications are given directly into a vein through intravenous infusion.
Investigational drugs: The trial uses two chemotherapy combinations. FOLFIRINOX combines fluorouracil, leucovorin, irinotecan, and oxaliplatin. FOLFOX combines fluorouracil, leucovorin, and oxaliplatin. Both work by interfering with cancer cell DNA, preventing the cells from growing and dividing. The study will run until October 2029.
Study on the Effectiveness of Fluorouracil, Levoleucovorin, and Oxaliplatin in Patients with Resected Small Bowel Adenocarcinoma
This Belgian trial focuses on patients who have already had surgery to completely remove their cancer. The study tests whether chemotherapy after surgery can prevent the cancer from returning. Patients are randomly assigned to either receive chemotherapy treatment or be observed without treatment.
Who can join:
- Patients who have had complete surgical removal of stage I, II, III, or IV small bowel adenocarcinoma
- Those 18 years or older who can attend scheduled visits and follow treatment plans
- Patients with no signs of remaining or spreading cancer after surgery, confirmed by physical examination and imaging scans
- Those able to start the study within 14 weeks after surgery and begin chemotherapy within 16 weeks
- ECOG Performance Status of 0 or 1, meaning fully active or having some symptoms but not needing bed rest
- Adequate blood counts, including white blood cells at least 1.5 x 109/l, platelets at least 100 x 109/l, and hemoglobin at least 90 g/l
- Proper liver and kidney function as measured by blood tests
Who cannot join:
- Patients who have not had surgery to remove the cancer
- Those with other types of cancer in addition to small bowel adenocarcinoma
- Patients who have already received chemotherapy or radiation therapy before the study
- Those with serious health conditions that could interfere with the study
- Pregnant or breastfeeding women
- Patients unable to follow study procedures or attend follow-up visits
- Those with allergies to the study medications
- Patients participating in another clinical trial at the same time
What the trial tests: The study compares different approaches after surgery: observation only, treatment with fluoropyrimidine alone, or treatment with fluoropyrimidine combined with oxaliplatin. The primary goal is to determine which approach best prevents cancer recurrence and improves disease-free survival. Secondary goals include evaluating overall survival and treatment side effects. The treatment period lasts 24 weeks.
Investigational drugs: Fluoropyrimidine is a chemotherapy medication that interferes with cancer cell growth. It can be used alone or combined with oxaliplatin, which damages cancer cell DNA. Oxaliplatin is a platinum-based chemotherapy drug. The medications are given either intravenously through a vein or orally as tablets, depending on the specific drug. The trial will continue until December 2030.
Summary
These two trials represent different approaches to treating small intestine adenocarcinoma. The French study focuses on advanced or metastatic disease that cannot be surgically removed, testing intensive chemotherapy combinations to slow disease progression. The Belgian study takes a different approach, examining whether chemotherapy after complete surgical removal can prevent cancer from coming back.
Both trials use similar drug families, particularly fluoropyrimidines and oxaliplatin, which are standard chemotherapy agents. The French trial additionally includes irinotecan in its FOLFIRINOX regimen. This reflects the current scientific interest in optimizing chemotherapy combinations for this rare cancer type.
The geographic distribution shows research activity in Western Europe, with one trial in each country. Both studies address significant unmet needs in treating this rare cancer, with the Belgian trial expected to conclude by the end of 2030 and the French trial by October 2029.
