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Study on FOLFOX Chemotherapy for Treating Advanced Colon Cancer in Patients Aged 70 and Older

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying colon cancer, specifically in patients who are 70 years old or older. The trial aims to explore the effectiveness of a treatment plan that includes a combination of medications known as FOLFOX, which consists of folinic acid, oxaliplatin, and fluorouracil. These medications are used as part of a chemotherapy regimen to treat cancer. The purpose of the study is to determine if patients who receive this chemotherapy before surgery have better outcomes compared to those who go directly to surgery.

Participants in the study will receive the chemotherapy treatment for six weeks, which is divided into three courses. After completing the chemotherapy, they will undergo surgery to remove the cancer. The study will monitor the participants over a period of time to see how well they respond to the treatment and to check if they remain free of cancer. The trial will also assess the safety of the treatment and any side effects that may occur.

The study will evaluate various aspects of the participants' health, including their quality of life and overall survival rates. It will also look at how the cancer responds to the treatment and whether the chemotherapy helps in reducing the size or spread of the cancer before surgery. The goal is to provide valuable information that could help improve treatment strategies for elderly patients with colon cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide written consent, confirming your understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your medical history and current health status, ensuring you meet the criteria for participation.
Step 3
Neoadjuvant chemotherapy
You will receive neoadjuvant chemotherapy for 6 weeks, consisting of 3 courses. The treatment involves the administration of three medications: folinic acid, oxaliplatin, and fluorouracil. These medications will be given through an intravenous (IV) line.
The specific schedule and dosage will be explained to you by the medical team. This phase aims to reduce the size of the tumor before surgery.
Step 4
Surgery
After completing the chemotherapy, you will undergo surgery to remove the tumor. The timing and details of the surgery will be discussed with you by your healthcare provider.
Step 5
Post-surgery assessment
Following surgery, your recovery and health status will be closely monitored. This includes evaluating the success of the surgery and any potential complications.
You will be assessed for any short-term effects of the chemotherapy and surgery, and your overall health will be evaluated.
Step 6
Follow-up
Regular follow-up appointments will be scheduled to monitor your health and check for any signs of cancer recurrence. These appointments will occur at various intervals, including 12 weeks, 1 year, and 3 years after surgery.
Your quality of life and overall well-being will be assessed using specific questionnaires designed for cancer patients.

Who can join the trial?

12 criteria

Must have a biopsy-confirmed adenocarcinoma of the colon. This means a small tissue sample from the colon has been tested and shows cancer.
Must have adequate renal biochemistry. This means the kidneys are working well enough based on blood tests.
Must have adequate hepatobiliary function. This means the liver and bile ducts are working well enough based on tests.
Must be able to understand and willing to provide written informed consent for the study. This means you agree to participate after being informed about the study details.
Must be affiliated with a social security scheme. This means you are part of a government or private program that provides health benefits.
Must have a radiological stage T3/T4 and N0/N1/N2 and M0. This refers to the size and spread of the cancer as seen on imaging tests.
Must be eligible for curative surgery. This means surgery is an option to try to remove all the cancer.
Must have no clinical or radiological evidence of bowel obstruction. This means there are no signs of a blockage in the intestines.
Must be 70 years or older at the time of registration.
Must have a pMMR/MSS tumor status. This refers to specific characteristics of the tumor that are determined by tests.
Must be assessed by a colon cancer specialist as fit to receive 6 weeks (3 courses) of NAC with FOLFOX and surgery. This means a doctor has determined you can handle the chemotherapy and surgery.
Must be homozygous for DPYD germline mutation. This means having a specific genetic makeup that affects how the body processes certain drugs.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than colon carcinoma cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are unable to give informed consent on their own cannot participate.
Patients who have had previous treatment for colon cancer cannot participate.
Patients with other serious medical conditions that could interfere with the study cannot participate.
Pregnant or breastfeeding women cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Assistance Publique Hopitaux De Paris
Verified
Paris, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

FOLFOX is a combination of chemotherapy drugs used to treat colon cancer. It includes three main medications: 5-fluorouracil, leucovorin, and oxaliplatin. These drugs work together to stop cancer cells from growing and dividing. 5-fluorouracil and leucovorin help to slow down or stop the growth of cancer cells, while oxaliplatin damages the DNA of cancer cells, which can lead to their death. This combination is given before surgery to shrink the tumor and make it easier to remove.

What is already known about the treatment

FOLFOX – FOLFOX is a combination chemotherapy regimen used to treat colon cancer, particularly in elderly patients with locally advanced but resectable colon cancer. It is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. The main goal of using FOLFOX in this context is to improve the chances of patients being alive and free of disease three years after treatment, compared to those who undergo surgery without prior chemotherapy. At the molecular level, FOLFOX works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is classified as an antineoplastic or anticancer treatment.

Investigated diseases

Colon Carcinoma – Colon carcinoma is a type of cancer that begins in the large intestine, specifically in the colon. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body, such as the liver or lungs. The progression of colon carcinoma can lead to symptoms like changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. The disease's advancement is often categorized by stages, which indicate the extent of spread within the colon and to other organs.