An open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria or by a transcriptomic treatment specific stratification signature (ESPAC-6)
This study, called ESPAC-6, is for people in the UK who have had a type of pancreatic cancer (pancreatic ductal adenocarcinoma) removed with surgery. It's an important step to see if we can improve how we treat this cancer after an operation. Researchers want to compare two ways of deciding which chemotherapy to give: the usual way doctors choose, and a newer method that uses information from your cancer cells to pick the most suitable chemotherapy. The goal is to see which approach is better at preventing the cancer from returning, helping you stay free of the disease for longer. They will be looking at how long people live without the cancer coming back, as well as checking overall survival, quality of life, and any side effects of the treatments.
At a glance
What is this study about?
This study is focused on a type of pancreatic cancer called pancreatic ductal adenocarcinoma. If you've had surgery to remove this cancer, this study wants to find the best follow-up treatment to stop it from coming back. After surgery, it's common to have chemotherapy to try and kill any remaining cancer cells that might be too small to see. This helps to reduce the chance of the cancer returning.
The main idea behind this study is to compare different chemotherapy approaches. Some people in the study will get chemotherapy chosen in the standard way, which doctors currently use. Other people will have their chemotherapy chosen based on a special test called 'transcriptomic stratification'. This test looks closely at the genes within your individual cancer cells to try and predict which chemotherapy might work best for you. The study will then compare how well these two methods work to keep the cancer away.
The researchers will be carefully tracking how long people stay free of cancer after their treatment. They'll also be looking at overall survival, which means how long people live after starting the study. Other important things they will check include your quality of life during treatment and any side effects you might experience. This helps them understand not just which treatment is most effective, but also how it impacts your daily life.
Key takeaways
- A study for people who have had pancreatic cancer surgery.
- Compares standard chemotherapy with a new, personalised approach.
- Aims to find the best way to prevent cancer recurrence.
- Will assess how long people stay cancer-free and their quality of life.
- Looks at common chemotherapy drugs like oxaliplatin and gemcitabine.
- Careful monitoring of side effects will be a key part of the study.
Who may be eligible?
To join this study, you would need to be an adult, 18 years old or older, and your sex doesn't matter – both men and women can take part.
The most important requirement is that you've recently had surgery to completely remove pancreatic ductal adenocarcinoma, which is a specific type of pancreatic cancer. The doctors involved in the study will need to confirm that your surgery was successful in removing all visible cancer before you can join.
There will also be other medical checks and tests to make sure that the treatment in the study would be safe and appropriate for you. For example, your general health, organ function, and any other medical conditions you have would be reviewed by the study team.
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 recently had surgery to remove pancreatic ductal adenocarcinoma?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you willing for your doctors to review your full medical history?
What does participation involve?
If you join this study, you would be randomly assigned to one of two groups: one receiving chemotherapy chosen by standard methods, and the other receiving chemotherapy chosen based on the special genetic test. You wouldn't get to choose which group you are in. The chemotherapy treatments themselves involve various medications like oxaliplatin or gemcitabine, given over a period of time. You would have regular visits to your hospital for these treatments, and for check-ups and tests. These tests would include blood tests and scans, to monitor your health, check for side effects, and see how well the treatment is working.
After your chemotherapy finishes, the study team will continue to follow your health and monitor for any signs of the cancer returning. This follow-up will involve regular appointments, likely including scans and check-ups, for several years. The total length of your participation would involve the treatment period itself, plus this longer-term monitoring, to fully understand the long-term effects of the different treatment approaches.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedSweden
Common questions
What is the main goal of this study?
The main goal is to find out which chemotherapy treatment after surgery is best at stopping pancreatic cancer from coming back.
What does 'transcriptomic stratification' mean?
It's a special test that looks at the genes in your cancer cells to help doctors choose the most suitable chemotherapy for you.
Will I get to choose my chemotherapy treatment?
No, if you join the study, you will be randomly assigned to receive chemotherapy chosen by standard methods or by the new genetic test.
What kind of tests will I have during the study?
You will have regular blood tests, scans, and check-ups to monitor your health, side effects, and how well the treatment is working.
How long will I be involved in the study?
You will be involved for the duration of your chemotherapy treatment, followed by several years of regular follow-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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