Study on the Effectiveness of Chemotherapy with Fluorouracil, Capecitabine, and Oxaliplatin for Patients with Small Bowel Adenocarcinoma

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What is this study about?

This clinical trial is focused on studying the effects of adjuvant chemotherapy in patients with small bowel adenocarcinoma, a type of cancer that occurs in the small intestine. The study will evaluate the benefits of using chemotherapy after surgical removal of the cancer. The medications being tested include Folinic Acid, Capecitabine, Fluorouracil, and Oxaliplatin. These drugs are commonly used in cancer treatment and will be administered in different combinations to see which is most effective.

The purpose of the study is to determine how well these chemotherapy treatments work compared to just observing patients after surgery. Participants will receive either 12 cycles of chemotherapy or 8 cycles if Capecitabine is used. The study will also compare the effectiveness of using Fluorouracil or Capecitabine alone versus in combination with Oxaliplatin. The trial will last for a period of up to 6 months, during which the patients’ health and response to the treatment will be closely monitored.

Throughout the study, the main focus will be on disease-free survival, which means the time patients remain free from cancer after treatment. Other aspects such as overall survival, side effects of the chemotherapy, and quality of life will also be assessed. The study aims to provide valuable information on the best treatment approach for patients with small bowel adenocarcinoma following surgery.

1 joining the study

Upon joining the study, you will be registered and randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the study treatments.

2 treatment plan

The study involves evaluating the benefit of adjuvant chemotherapy after surgery for small bowel adenocarcinoma. Adjuvant chemotherapy is additional cancer treatment given after the primary treatment to lower the risk of the cancer returning.

You may receive one of the following treatments: 12 cycles of chemotherapy with fluorouracil and oxaliplatin, or 8 cycles of chemotherapy with capecitabine. The specific medications and their combinations will depend on the group you are assigned to.

3 medication administration

Folinic acid and fluorouracil will be administered through an intravenous (IV) infusion, which means the medication is given directly into a vein.

Capecitabine is taken orally, meaning you will swallow the medication in pill form.

Oxaliplatin is also administered through an IV infusion.

4 treatment duration

The treatment will last for either 12 cycles or 8 cycles, depending on the specific chemotherapy regimen you are assigned to. Each cycle typically lasts a few weeks, and your healthcare team will provide specific details about the schedule.

5 follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. During these visits, your overall survival and any side effects from the chemotherapy will be assessed.

Your quality of life will also be evaluated using specific questionnaires designed to understand how the treatment affects your daily life.

6 end of study participation

Your participation in the study will conclude after the completion of the treatment cycles and follow-up assessments. The study aims to determine the disease-free survival, which is the time from randomization to the first occurrence of cancer recurrence, a new primary tumor, or death.

Who Can Join the Study?

The patient must have had a complete surgical removal (called R0 resection) of stage I, II, or III small bowel adenocarcinoma.
The patient must provide a dated and signed informed consent before joining the study.
No remaining or spread of cancer should be visible on a CT or MRI scan of the chest, abdomen, and pelvis.
The patient must be registered and randomly assigned to a treatment group within 12 weeks after surgery and should be able to start chemotherapy within 14 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 during the day.
The patient must be at least 18 years old.
Blood tests must show: neutrophils (a type of white blood cell) of at least 2000 per mm³, platelets (cells that help with blood clotting) of at least 100,000 per mm³, hemoglobin (a protein in red blood cells) of at least 9 g/dL (transfusions are allowed), and bilirubin (a substance made during the breakdown of red blood cells) no more than 1.5 times the upper limit of normal.
ASAT and ALAT (liver enzymes) must be no more than 2.5 times the upper limit of normal.
Creatinine clearance (a measure of kidney function) must be greater than 50 mL/min, calculated using the Cockcroft-Gault formula.
Women who can have children must use contraception during treatment and for at least 4 months after stopping treatment. Men must use contraception during treatment and for at least 6 months after stopping treatment. Post-menopausal women must have not had a menstrual period for at least 12 months to be considered not able to have children.

Who Cannot Join the Study?

Patients who have not had surgery to remove stage I-III small bowel adenocarcinoma cannot participate.
Patients who are unable to undergo chemotherapy treatment cannot participate.
Patients with other types of cancer that have not been treated or are currently being treated cannot participate.
Patients with serious health conditions that could interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.

Where you can join this trial?

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Site Name	City	Country	Status
Azzgohxolh Pnonmeao Hytbhyvo Dc Pqddl	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	04.02.2016

Trial locations

Investigated drugs:

5-FU is a type of chemotherapy medication used in this clinical trial. It works by interfering with the growth and spread of cancer cells in the body. In this study, it is used as an adjuvant treatment, which means it is given after surgery to help reduce the risk of cancer coming back. Patients may receive 5-FU alone or in combination with another medication to see which approach is more effective.

Capecitabine is another chemotherapy medication being tested in the trial. It is taken orally and is designed to stop cancer cells from growing and dividing. Like 5-FU, capecitabine is used as an adjuvant treatment after surgery for small bowel adenocarcinoma. The trial aims to determine if capecitabine alone or in combination with another drug is more beneficial for patients.

Oxaliplatin is a chemotherapy drug that is used in combination with either 5-FU or capecitabine in this study. It works by damaging the DNA of cancer cells, which prevents them from multiplying. The trial is investigating whether adding oxaliplatin to the treatment regimen improves outcomes for patients who have had surgery for small bowel adenocarcinoma.

Investigated diseases:

Small intestine adenocarcinoma

Small Bowel Adenocarcinoma – Small bowel adenocarcinoma is a type of cancer that originates in the glandular cells lining the small intestine. It typically begins in the duodenum, jejunum, or ileum, which are parts of the small intestine. The disease progresses as the cancer cells grow and invade surrounding tissues, potentially spreading to nearby lymph nodes and other organs. As the tumor enlarges, it can cause blockages in the intestine, leading to symptoms such as abdominal pain, nausea, and weight loss. Over time, the cancer may metastasize to distant organs, complicating the disease course. The progression of small bowel adenocarcinoma can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-515299-11-00

Protocol code:

PRODIGE 33 -BALLAD

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Chemotherapy with Fluorouracil, Capecitabine, and Oxaliplatin for Patients with Small Bowel Adenocarcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?