First adjuvant trial in locally resected aggressive pancreatic neuroendocrine tumors: a randomized phase III investigating the efficacy of systemic chemotherapy (ADJUPANET)
This research study, called ADJUPANET, focuses on a specific type of pancreatic cancer called pancreatic neuroendocrine tumours (PanNETs). These are treated with surgery to remove the tumour. The study wants to find out if giving chemotherapy, using a combination of capecitabine and temozolomide, after successful surgery helps prevent the cancer from returning. They are comparing this chemotherapy treatment to just carefully watching patients after surgery (standard observation) to see which approach works best. The main thing they're measuring is how long patients live without their cancer coming back. The study is for adults over 18 who have had aggressive PanNETs removed.
At a glance
What is this study about?
This clinical trial is designed to help us understand the best way to care for people who have had a specific type of pancreatic cancer called a pancreatic neuroendocrine tumour (PanNET). These tumours are sometimes described as 'aggressive' because they can grow and spread, even after surgery. If the tumour has been completely removed through surgery, doctors want to know if giving extra treatment afterwards can help stop the cancer from coming back.
In this study, patients who have had their aggressive PanNET completely removed will be put into one of two groups. One group will receive a combination of chemotherapy medicines called capecitabine and temozolomide for a period of time after their surgery. The other group will simply be monitored closely by their doctors without receiving any additional cancer drugs. The main goal is to see which approach leads to patients staying cancer-free for longer.
This is a 'Phase III' study, which means it's a large, important trial designed to confirm if a new treatment is better than existing options. The results will help doctors decide on the most effective treatment plan for people after surgery for aggressive PanNETs, aiming to improve their long-term health and prevent the cancer's return.
Key takeaways
- This study investigates if chemotherapy after surgery prevents aggressive pancreatic neuroendocrine tumours from returning.
- It compares chemotherapy (capecitabine and temozolomide) with careful observation after surgery.
- The main aim is to see which approach leads to longer periods without cancer returning.
- It's for adults over 18 who have had their aggressive PanNET completely removed.
- The results will help doctors decide future best treatments for this type of cancer.
Who may be eligible?
To take part in this study, you would generally need to be at least 18 years old. Both men and women can participate.
The most important requirement is that you've had a specific type of pancreatic cancer, called an aggressive pancreatic neuroendocrine tumour (PanNET), completely removed by surgery. This means that doctors are confident they got all of the visible cancer during the operation.
There will be other detailed medical checks to make sure your overall health is suitable for the treatments involved and that the study is right for you. Your doctor or the study team will go through all of these points with you carefully.
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 an aggressive pancreatic neuroendocrine tumour (PanNET)?
- Has your PanNET been completely removed through surgery?
- Are you generally well enough to potentially receive chemotherapy?
What does participation involve?
If you join this study, your involvement would depend on which treatment group you are in. If you are in the chemotherapy group, you will take specific medications (capecitabine and temozolomide) as tablets or capsules for a set period after your surgery. You would have regular appointments to attend where doctors will check your progress, look for any side effects, and monitor your health carefully. This would involve physical examinations and blood tests.
If you are in the observation group, you will not receive the chemotherapy drugs but will still have regular check-ups, scans, and blood tests, similar to the chemotherapy group, to monitor your health and watch for any signs of the cancer returning.
Both groups will be followed for a long period to see how well the treatments work over time. The study team will explain the exact schedule of visits, tests, and how long your participation would last, including follow-up after your treatment ends.
Potential risks and benefits
Locations (1)
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Common questions
What is a pancreatic neuroendocrine tumour (PanNET)?
It's a rare type of cancer that starts in the hormone-producing cells of the pancreas, which is a gland behind your stomach.
What does 'adjuvant' mean in this study's title?
It means the treatment is given after the main treatment (surgery, in this case) to help prevent the cancer from coming back.
What are capecitabine and temozolomide?
These are chemotherapy drugs often used to treat certain cancers by stopping cancer cells from growing and dividing.
Why isn't everyone getting chemotherapy?
The study needs to compare the chemotherapy group with a group that only receives standard monitoring after surgery to see if the chemotherapy is truly more effective.
Will I know which group I'm in?
Yes, for this study, you will know whether you are receiving the chemotherapy or if you are in the observation group.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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