PRODIGE 104 – NEOPREDICT A multicenter phase II trial using transcriptomic signatures to personalize neoadjuvant chemotherapy for patients with resectable borderline pancreatic adenocarcinoma.
This study, called PRODIGE 104 – NEOPREDICT, is for people with a type of pancreatic cancer that doctors believe can be removed with surgery, but might be a bit tricky. It’s a Phase II trial, meaning it's still in the earlier stages of testing new treatments. We are exploring whether using information from a patient's genes can help choose the best chemotherapy treatment before surgery. This personalised approach aims to improve how well the treatment works and ultimately help patients live longer without their cancer coming back. The study will look at how many people are still alive and well a year after starting treatment.
At a glance
What is this study about?
This study, called PRODIGE 104 – NEOPREDICT, is looking into better ways to treat a specific type of pancreatic cancer. This type of cancer is called 'resectable borderline pancreatic adenocarcinoma', which means doctors think it might be possible to remove it with surgery, but it could be challenging. In this study, we're focusing on 'neoadjuvant chemotherapy'. This simply means giving chemotherapy medicines before surgery to try and shrink the tumour or stop it from spreading, which can make the surgery more successful.
The main idea behind this study is 'personalising' treatment. Instead of giving everyone the same chemotherapy, we want to see if we can use information from a patient's genes, called 'transcriptomic signatures', to decide which chemotherapy medicines might work best for them. The study is comparing different combinations of chemotherapy drugs including Apexelsin, FOLINATE DE CALCIUM HIKMA, OXALIPLATINE KABI, GEMCITABINE HIKMA, FLUOROURACILE TEVA, and IRINOTECAN MEDAC. The goal is to find out if this personalised approach leads to better results for patients.
We will be looking at how well patients are doing one year after their treatment started, particularly if their cancer hasn't come back and they are still alive. We will also be tracking other important things like how much the tumours shrink, how often surgery is successful, how long people live overall, and their quality of life. This research is incredibly important because it could lead to more effective and tailored treatments for pancreatic cancer, giving patients better chances.
Key takeaways
- This study explores a personalised chemotherapy approach for a specific pancreatic cancer.
- Chemotherapy is given before surgery to try and improve outcomes.
- It's a Phase II study, which means it's an early-stage effectiveness and safety test.
- The study aims to see if personalising treatment leads to better long-term survival without cancer.
- Participation involves chemotherapy, potential surgery, and follow-up appointments.
- You can withdraw from the study at any time.
Who may be eligible?
To be part of this study, you need to meet certain requirements. The main ones are that you are an adult, aged 18 years or older, and your doctors have diagnosed you with 'resectable borderline pancreatic adenocarcinoma'. This is a specific type of pancreatic cancer that they believe can potentially be removed by surgery. Both men and women can take part in this study.
There might be other health requirements that your doctors will need to check to make sure the study is safe and right for you. They will review all your medical information carefully. It's important to remember that not everyone who wants to join a study can, as specific health conditions or current treatments might mean it's not suitable.
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 resectable borderline pancreatic adenocarcinoma?
- Are you able to receive chemotherapy treatments?
- Are you willing to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, it would involve several steps. You would have appointments for assessments to check your health and the details of your cancer. You would then receive chemotherapy treatments, which are given before any potential surgery. These treatments are given as infusions, meaning the medication goes directly into your bloodstream, and this would happen over about four months.
During your chemotherapy, you would have regular checks to see how you are doing and to monitor for any side effects. After the chemotherapy, if appropriate, you would have surgery. Following treatment, there would be follow-up appointments to track your health and see how well the treatment has worked over time. We would also ask you about your quality of life. The total duration of your participation in the study, including follow-up, would be determined by the study plan, which your doctor can explain in full detail.
Potential risks and benefits
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Common questions
What is 'personalized chemotherapy'?
It means using information from your genes to help doctors choose the chemotherapy medicines that are most likely to work best for you.
What does 'neoadjuvant' mean?
It means the chemotherapy is given before surgery, with the aim of shrinking the tumour or stopping it from spreading, to make surgery more successful.
What is a 'Phase II trial'?
This is an earlier stage of drug testing. It mainly looks at whether a new treatment is effective and safe in a small group of people with the condition.
Will I definitely have surgery in this study?
The aim is for surgery if appropriate after chemotherapy, but your doctors will decide based on how well the chemotherapy works and your health.
How long will the chemotherapy treatment last?
The planned chemotherapy treatment period is for about four months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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