Study on the Effectiveness of Fluorouracil, Levoleucovorin, and Oxaliplatin in Patients with Resected Small Bowel Adenocarcinoma

3 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of adjuvant chemotherapy for patients with small bowel adenocarcinoma, a type of cancer that occurs in the small intestine. The study aims to evaluate the effectiveness of different chemotherapy treatments following surgery. The treatments being tested include a regimen of fluoropyrimidine alone and a combination of fluoropyrimidine with Oxaliplatin. These medications are used to help prevent the cancer from returning after it has been surgically removed.

The trial will compare the outcomes of patients who receive chemotherapy with those who are simply observed after surgery. Participants will be randomly assigned to one of these groups. The study will last for 24 weeks, during which patients will receive their assigned treatment. The goal is to determine which approach is more effective in preventing the recurrence of cancer and improving overall survival rates.

Throughout the study, patients will be monitored for any side effects and their overall health will be assessed. The trial will also gather information on the characteristics of the cancer and how it responds to treatment. This research is part of a larger global effort to improve treatment options for small bowel adenocarcinoma and to better understand the disease. The findings from this study could help guide future treatment decisions for patients with this type of cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required to participate.

Eligibility criteria include having undergone surgery for small bowel adenocarcinoma and meeting specific health parameters.

2 randomization

The patient will be randomly assigned to one of two groups: observation or chemotherapy treatment.

This process ensures that the study results are unbiased and scientifically valid.

3 chemotherapy treatment

If assigned to the chemotherapy group, the patient will receive treatment for 24 weeks.

The treatment may involve a fluoropyrimidine monotherapy or a combination of fluoropyrimidine and oxaliplatin.

4 medication administration

Medications include fluorouracil, levoleucovorin, oxaliplatin, and capecitabine.

Fluorouracil and levoleucovorin are administered via intravenous infusion.

Oxaliplatin is also given through intravenous infusion.

Capecitabine is taken orally in the form of film-coated tablets.

5 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment will be closely monitored.

Regular visits and tests will be scheduled to assess the patient’s condition and any side effects.

6 end of trial

The trial is expected to conclude by December 31, 2030.

The primary goal is to evaluate disease-free survival, while secondary goals include overall survival and treatment side effects.

Who Can Join the Study?

The patient must have had a complete removal of a tumor in the small intestine, known as R0 resected stage I, II, III, or IV small bowel adenocarcinoma.
The level of serum bilirubin, a substance made by the liver, must be less than or equal to 1.5 times the upper limit of normal.
The patient must sign and date a form showing they understand the important details of the trial before joining.
The patient must be 18 years old or older.
The patient must be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other trial procedures.
There should be no signs of remaining or spreading cancer after surgery, as shown by a physical examination and imaging tests like CT or MRI scans of the chest, abdomen, and pelvis.
The patient must be registered and randomly assigned to a treatment group within 14 weeks after surgery and start chemotherapy within 16 weeks after surgery.
The patient must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
The absolute neutrophil count, a type of white blood cell count, must be at least 1.5 x 10⁹/l.
The platelet count, which helps with blood clotting, must be at least 100 x 10⁹/l.
The hemoglobin level, which carries oxygen in the blood, must be at least 90 g/l. Previous blood transfusions are allowed.
The levels of AST and ALT, enzymes that indicate liver function, must be less than or equal to 2.5 times the upper limit of normal. At least one of these tests must be done.
The creatinine clearance, a measure of kidney function, must be greater than 50 ml/min, calculated by specific equations or measured directly.

Who Cannot Join the Study?

Patients who have not had surgery to remove the small bowel adenocarcinoma cannot participate.
Patients who have other types of cancer, not just small bowel adenocarcinoma, are excluded.
Patients who have had chemotherapy or radiation therapy for small bowel adenocarcinoma before the study cannot join.
Patients with serious health conditions that could interfere with the study are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend follow-up visits are excluded.
Patients who have allergies to the study medications cannot participate.
Patients who are part of another clinical trial at the same time are not allowed to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
AZ Turnhout	Turnhout	Belgium
Sint-Lucas General Hospital	Brugge	Belgium
CHC MontLegia	Liege	Belgium
Cahwcnotu Uloonpduubnajp Sjrgsbszv	Woluwe-Saint-Lambert	Belgium
Urpfvndgyj Oz Axqpzdu	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.02.2020

Trial locations

Investigated drugs:

Fluoropyrimidine is a type of chemotherapy medication used in this trial as a single treatment option. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. This medication is being tested to see how effective it is when used alone after surgery in patients with small bowel adenocarcinoma.

Oxaliplatin is another chemotherapy medication included in the trial. It is used in combination with fluoropyrimidine to see if the two drugs together are more effective than fluoropyrimidine alone. Oxaliplatin works by damaging the DNA of cancer cells, which can lead to their death. This combination therapy is being evaluated for its potential benefits in treating small bowel adenocarcinoma after surgery.

Investigated diseases:

Small intestine adenocarcinoma

Small Bowel Adenocarcinoma – This is a rare type of cancer that originates in the small intestine, specifically in the glandular cells lining the small bowel. It often begins as a small growth or polyp that can become cancerous over time. As the disease progresses, it may invade deeper layers of the intestine and potentially spread to nearby lymph nodes or other organs. Symptoms can include abdominal pain, weight loss, and changes in bowel habits, but they may not appear until the disease is advanced. The progression of the disease can vary, with some cases remaining localized while others may spread more extensively.

Trial ID:

2024-518349-85-01

Protocol code:

Ballad Belgium

NCT ID:

NCT04257461

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effectiveness of Fluorouracil, Levoleucovorin, and Oxaliplatin in Patients with Resected Small Bowel Adenocarcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?