Recruiting

Study on Preoperative Treatment with mFOLFIRINOX or Gemcitabine-Paclitaxel for Patients with Borderline Resectable Pancreatic Cancer

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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 pancreatic adenocarcinoma, a type of cancer that begins in the tissues of the pancreas. The study will explore the effectiveness of a treatment regimen called mFOLFIRINOX or Gem-Nab-P, which may be combined with a specialized form of radiation therapy known as isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT). The purpose of the study is to compare the outcomes of patients receiving standard chemotherapy with those receiving the experimental combination of chemotherapy and radiation therapy.

Participants in the study will receive treatment over a period of up to 16 weeks. The medications involved in the study include Fluorouracil, Gemcitabine, Folinic Acid, Irinotecan Hydrochloride Trihydrate, Oxaliplatin, and Paclitaxel. These medications are administered through an infusion, which means they are delivered directly into the bloodstream. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatment.

The study aims to determine the effectiveness of the treatments in achieving a successful surgical removal of the tumor and improving the time patients remain free from the disease. It will also assess other factors such as the rate of tumor removal, the time without cancer spreading, and the overall survival of participants. The trial will help in understanding the potential benefits and risks of combining chemotherapy with radiation therapy for treating 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
Joining the trial
Upon joining the trial, you will be assigned to one of two groups. One group will receive a standard chemotherapy treatment, while the other group will receive an experimental chemotherapy treatment combined with a specialized radiation therapy called stereotactic body radiation therapy (SBRT).
Step 2
Treatment phase
During the treatment phase, you will receive medications through an infusion, which is a way to deliver drugs directly into your bloodstream. The medications used in this trial include fluorouracil, gemcitabine, folinic acid, irinotecan hydrochloride trihydrate, oxaliplatin, and paclitaxel. The specific combination and dosage will depend on the group you are assigned to.
The treatment will be administered in cycles, with each cycle lasting a few weeks. The exact duration and frequency of the cycles will be explained to you by the medical team.
Step 3
Monitoring and assessments
Throughout the trial, regular monitoring and assessments will be conducted to evaluate your health and the effectiveness of the treatment. This will include blood tests, imaging scans, and other necessary evaluations.
The medical team will closely observe for any side effects or adverse reactions to the treatment. It is important to report any symptoms or concerns to the medical staff promptly.
Step 4
Completion of treatment
After completing the treatment cycles, further assessments will be conducted to determine the outcome of the treatment. This may include additional imaging scans and laboratory tests.
The results will help the medical team understand the effectiveness of the treatment and plan any necessary follow-up care.
Step 5
Follow-up period
Following the completion of the trial, a follow-up period will be scheduled to monitor your long-term health and any lasting effects of the treatment.
Regular check-ups and assessments will be part of this follow-up to ensure your well-being and to gather data for the study.

Who can join the trial?

15 criteria

Must have a confirmed diagnosis of adenocarcinoma (a type of cancer) in the pancreas, specifically in the head, uncinated process, body, or tail of the pancreas. This diagnosis should be verified by a local pathologist.
Must have a cancer stage of cTNM stage: T1-4 N0-2 M0, which describes the size and extent of the tumor and whether it has spread to lymph nodes or other parts of the body.
The cancer must be confirmed as borderline resectable (meaning it might be possible to remove it with surgery) by a team of specialists after reviewing a detailed CT scan or MRI with contrast.
Must not have received any prior chemotherapy or radiation treatment for pancreatic cancer, unless it was part of a specific pre-surgery treatment plan.
Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
Must not have grade ≥ 2 neuropathies, which are moderate to severe nerve problems.
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Must meet specific laboratory test results, including:
- Absolute neutrophil count (ANC) of at least 1,500/mm³ (a measure of a type of white blood cell).
- Platelet count of at least 100,000/mm³ (a measure of cells that help with blood clotting).
- Hemoglobin level of at least 9 g/dL (a measure of red blood cells).
- Creatinine level no more than 1.5 times the upper limit of normal, or an estimated GFR (kidney function) greater than 45 mL/min.
- Bilirubin level no more than 1.5 times the upper limit of normal, even after a successful bile duct stent placement.
- AST/ALT levels no more than 2.5 times the upper limit of normal (liver enzymes).
- CA 19.9 level less than 2500 kU/l, which is a marker sometimes elevated in pancreatic cancer, and no signs of bile duct blockage.
- Open to both male and female participants.
- Participants must be within a certain age range, typically adults.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides pancreatic adenocarcinoma cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients with severe heart problems cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with known allergies to the study drugs cannot participate.
Patients with a history of drug or alcohol abuse within the last 2 years cannot participate.
Patients who are unable to follow the study procedures cannot participate.

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Verified sites

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

Verified
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

mFOLFIRINOX
is a combination of chemotherapy drugs used to treat pancreatic cancer. It includes several medications that work together to stop cancer cells from growing and dividing. This treatment is often used before surgery to shrink the tumor and make it easier to remove.
Gem-Nab-P
is a combination of two chemotherapy drugs, gemcitabine and nab-paclitaxel, used to treat pancreatic cancer. These drugs work by interfering with the growth of cancer cells, slowing down or stopping their spread. This combination is used to help reduce the size of the tumor before surgery.
Isotoxic High-Dose Stereotactic Body Radiation Therapy (iHD-SBRT)
is a type of radiation therapy that delivers high doses of radiation to the tumor with precision. This therapy aims to target the cancer cells while minimizing damage to the surrounding healthy tissue. It is used in combination with chemotherapy to enhance the treatment's effectiveness before surgery.

Paclitaxel Albumin-Bound

What is already known about the treatment

mFOLFIRINOX
This medication is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently used in clinical trials for treating pancreatic adenocarcinoma, a type of pancreatic cancer. The main purpose of mFOLFIRINOX is to shrink tumors before surgery, making them easier to remove. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. mFOLFIRINOX is classified as a combination chemotherapy regimen, which means it uses multiple drugs to attack cancer cells in different ways.
Gem-Nab-P
This medication is also given intravenously and is being studied for its effectiveness in treating pancreatic adenocarcinoma. It is used to help reduce the size of tumors before surgical removal. Gem-Nab-P works by disrupting the growth of cancer cells, targeting their ability to multiply. It falls under the category of chemotherapy, specifically as a combination of gemcitabine and nab-paclitaxel, which work together to enhance the treatment's effectiveness against cancer cells.

Investigated diseases

Pancreatic adenocarcinoma – Pancreatic adenocarcinoma is a type of cancer that originates in the tissues of the pancreas, specifically in the ducts that carry digestive enzymes. It typically begins as a small lesion in the pancreatic ductal cells and can grow to invade nearby tissues and organs. As the disease progresses, it may spread to lymph nodes and distant organs such as the liver and lungs. The growth of the tumor can obstruct the bile duct, leading to jaundice, and may also cause abdominal pain and weight loss. Over time, the cancer can lead to complications such as diabetes due to the pancreas's role in insulin production. The progression of pancreatic adenocarcinoma is often aggressive, with the potential for rapid advancement.