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Study on Survival in Patients with Resectable Pancreatic Cancer Using Irinotecan, Fluorouracil, Calcium Folinate, and Oxaliplatin Combination Therapy

Fast replyRegistered 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 the treatment of resectable pancreatic cancer, a type of cancer that can be surgically removed but has certain risk factors. The study involves a treatment plan that includes a combination of medications and therapies. The medications used in this study are irinotecan, fluorouracil, calcium folinate, and oxaliplatin. These medications are administered through an infusion, which means they are given directly into the bloodstream over a period of time.

The purpose of the study is to evaluate the overall survival of patients who undergo a specific treatment sequence. This sequence includes initial treatment with a combination of chemotherapy drugs known as mFOLFIRINOX and radiotherapy, followed by surgery to remove the cancer, and then additional chemotherapy. The study will compare the survival data of these patients with those who receive surgery followed by mFOLFIRINOX chemotherapy without the initial treatment.

Participants in the study will follow a treatment plan over a period of time, with regular monitoring to track their progress. The study aims to gather information on how long patients live after starting treatment, as well as other factors such as the time they remain free from invasive disease, the number of treatment cycles completed, and any new symptoms or side effects that may occur. The study will also assess the quality of life of participants using a questionnaire. The goal is to better understand the effectiveness of the treatment plan and improve outcomes for patients with resectable pancreatic cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial chemotherapy
Upon joining the study, the first step involves receiving a combination of medications known as mFOLFIRINOX. This includes four drugs: irinotecan, fluorouracil, calcium folinate, and oxaliplatin.
These medications are administered through an infusion, which means they are given directly into the bloodstream through a vein. The specific dosage and frequency will be determined by the medical team based on individual health needs.
Step 2
Radiotherapy
Following the initial chemotherapy, the next step is radiotherapy. This treatment uses high-energy rays to target and kill cancer cells.
The duration and frequency of radiotherapy sessions will be scheduled by the healthcare provider, ensuring the treatment is tailored to the patient's condition.
Step 3
Surgery
After completing the neoadjuvant treatments, the next phase involves surgery to remove the pancreatic tumor.
The surgical procedure aims to eliminate cancerous tissue and is a critical step in the treatment process.
Step 4
Adjuvant chemotherapy
Post-surgery, the patient will undergo adjuvant chemotherapy to help eliminate any remaining cancer cells and reduce the risk of recurrence.
This phase also involves the administration of the mFOLFIRINOX regimen, similar to the initial chemotherapy, with the schedule and dosage adjusted as necessary.
Step 5
Follow-up and monitoring
After completing all treatment phases, regular follow-up appointments will be scheduled to monitor health and check for any signs of cancer recurrence.
These appointments may include physical exams, imaging tests, and blood tests to ensure ongoing health and well-being.

Who can join the trial?

10 criteria

Patients must have been diagnosed with resectable adenocarcinoma of the pancreas and have at least 2 risk factors.
Patients must be able to understand and be willing to sign a written informed consent document.
A histological diagnosis of pancreatic adenocarcinoma must be confirmed by a procedure called fine needle aspiration puncture, which is performed using an endoscopic ultrasound.
Patients must not have received any prior therapy for pancreatic cancer.
Patients must have an ECOG score of less than 2. The ECOG score is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
If needed, patients must have had biliary drainage before starting treatment. This is required if bilirubin levels are higher than 1.5 mg/dl.
Patients must be older than 18 years and younger than 70 years. Patients aged between 71 and 75 years can be included if they pass a test called the GERIATRIC 8 (G8) frailty test with a score greater than 14 points, indicating they are 'not fragile'.
Patients must not have had a cerebrovascular accident (stroke) or myocardial infarction (heart attack) in the 6 months before starting treatment.
Women who can have children and sexually active men must agree to use effective birth control methods, such as hormonal methods, barrier methods, or abstinence, before and during the study.
Patients must have normal function of their organs and bone marrow.

Who cannot join the trial?

7 criteria

Patients who do not have resectable pancreatic adenocarcinoma with risk factors cannot participate. This means the cancer must be in the pancreas and able to be removed by surgery.
Patients who have not completed neoadjuvant treatment with mFOLFIRINOX and radiotherapy are excluded. Neoadjuvant treatment is therapy given before the main treatment to shrink a tumor.
Patients who have not undergone surgery and then adjuvant chemotherapy are excluded. Adjuvant chemotherapy is additional cancer treatment given after the primary treatment to lower the risk of the cancer returning.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group are excluded.
Both male and female patients are eligible, but those who do not meet other criteria are excluded.
Patients who are considered part of a vulnerable population may be excluded. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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

Complejo Hospitalario Universitario Insular Materno Infantil
Verified
Las Palmas De Gran Canaria, Spain
Complexo Hospitalario Universitario De Vigo
Responsive
Vigo, Spain
El Hospital Universitario De Gran Canaria Dr. Negrin
Verified
Las Palmas De Gran Canaria, Spain

Trial locations

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Investigated drugs

mFOLFIRINOX
is a combination of chemotherapy drugs used to treat pancreatic cancer. It includes four different medications that work together to stop cancer cells from growing and spreading. This treatment is given before surgery to shrink the tumor and make it easier to remove. After surgery, it is also used to kill any remaining cancer cells and reduce the risk of the cancer coming back.
Radiotherapy
is a treatment that uses high-energy rays to target and destroy cancer cells. In this trial, radiotherapy is used before surgery to help shrink the tumor, making it easier to remove. It works by damaging the DNA of cancer cells, which stops them from growing and dividing.

What is already known about the treatment

mFOLFIRINOX – mFOLFIRINOX is a combination chemotherapy regimen administered intravenously, typically used in the treatment of pancreatic cancer. It is currently recognized in medical literature as a standard treatment option for patients with resectable pancreatic adenocarcinoma, especially those with risk factors. The main therapeutic indication for mFOLFIRINOX is to improve survival rates in these patients by shrinking tumors before surgery and eliminating remaining cancer cells afterward. At the molecular level, mFOLFIRINOX works by interfering with the DNA replication and repair processes of cancer cells, thereby inhibiting their growth and division. It is classified pharmacologically as a cytotoxic chemotherapy regimen.

Investigated diseases

Resectable Pancreatic Adenocarcinoma with Risk Factors – This is a type of cancer that originates in the tissues of the pancreas, specifically in the cells that line the ducts of the pancreas. It is considered resectable when the tumor can be surgically removed. The disease progresses as the cancer cells grow and potentially spread to nearby tissues and organs. Risk factors may include genetic predispositions, lifestyle factors, or other health conditions that increase the likelihood of cancer development. As the disease advances, it may invade surrounding structures and potentially metastasize to distant organs. The progression can lead to various complications depending on the extent and location of the tumor growth.