A randomized phase III trial of short-course versus long-course pre-operative chemotherapy with mFOLFIRINOX or PAXG regimen for stage I-III pancreatic ductal adenocarcinoma (PDAC)
This study is for people with pancreatic cancer that hasn't spread (stages I-III). Researchers are comparing two different ways of giving chemotherapy before surgery. One group will receive a shorter course of chemotherapy, and another group will receive a longer course. Both groups will use common chemotherapy medicines. The main goal is to find out if one approach is more effective at stopping the cancer from growing or coming back, measured by how long people live without the disease getting worse. It also looks at how well the treatments shrink the cancer, side effects, and how people feel during treatment.
At a glance
What is this study about?
This research study is looking at pancreatic cancer. Pancreatic cancer starts in the pancreas, an organ in your tummy that helps with digestion and making hormones. When the cancer is in stages I to III, it means it hasn't spread to distant parts of the body, and surgery might be an option. Before surgery, doctors often give chemotherapy to try and shrink the tumour and make the operation more successful.
In this study, doctors want to find the best way to give this chemotherapy before surgery. They are comparing two different schedules: a shorter course of treatment versus a longer course. Both schedules use medicines that are already known to treat cancer, like Abraxane, Leucovorin, and Oxaliplatin. The main aim is to see which schedule is better at preventing the cancer from growing or coming back, and helping people live longer and healthier lives.
Researchers will also be looking at other important things. This includes how much the tumour shrinks, how many side effects people experience, how successful the surgery is, and how patients feel during and after treatment. By comparing these different approaches, the study hopes to improve how pancreatic cancer is treated in the future.
Key takeaways
- Compares two different schedules of chemotherapy before surgery for pancreatic cancer.
- Aims to find out if a shorter or longer course of chemo works better.
- For pancreatic cancer that hasn't spread (stages I-III).
- Uses chemotherapy medicines already approved for cancer treatment.
- Will look at how well the treatment works, side effects, and quality of life.
Who may be eligible?
This study is open to adults aged 18 and over, regardless of whether they are male or female. You would be considered for this study if you have been diagnosed with pancreatic cancer that is in stage I, II, or III. This means the cancer has not spread to other organs in your body.
Before you can join, doctors will need to check your general health and that your specific type of pancreatic cancer fits the study's requirements. This often involves looking at your medical history, recent scans, and blood tests to make sure the treatment would be safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with pancreatic cancer that is stage I, II, or III?
- Is your doctor considering surgery as part of your treatment plan?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to confirm you’re a good fit. Once you’ve joined, you would be randomly assigned to one of two groups: either a shorter course or a longer course of chemotherapy before your surgery. Both groups will receive standard chemotherapy medicines given through a drip (infusion).
You would have regular appointments at the hospital for your chemotherapy treatments, which might involve several visits over a period of weeks or months, depending on which group you are in. During these visits, doctors and nurses will monitor your health, check for any side effects, and perform tests like blood tests and scans (like CT or MRI scans) to see how the treatment is working. After your surgery, you would have follow-up appointments to track your recovery and monitor your health over time. The total duration of your involvement, including treatment and follow-up, would be fully explained to you before you commit.
Potential risks and benefits
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Common questions
What is 'short-course' versus 'long-course' chemotherapy?
It means how long you receive chemotherapy medicines before your surgery. One group gets treatment for a shorter period, and the other for a longer period.
What stage of pancreatic cancer is this study for?
This study is for pancreatic cancer that is in stages I, II, or III, meaning it hasn't spread to other parts of your body.
What kind of medicines will I receive?
You'll receive a combination of medicines commonly used for chemotherapy, given as a drip, such as Abraxane, Leucovorin, Gemcitabine, and others.
Will I still have surgery if I join this study?
Yes, the study is designed for patients who will have surgery for their pancreatic cancer after receiving chemotherapy.
Will I get to choose which chemotherapy course I receive?
No, you will be randomly assigned to either the short-course or long-course group, like picking a card from a shuffled deck.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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