Ongoing, recruitingTherapeutic use (Phase IV)Interventional

SURVIVAL ANALYSIS AFTER NEOADJUVANT TREATMENT IN RESECTABLE PANCREATIC CANCER WITH RISK FACTORS

This study is called a 'phase IV' trial, which means it's looking at how well existing treatments work in real life. It focuses on people with a specific type of pancreatic cancer that doctors believe can be fully removed by surgery, but who also have certain 'risk factors' that might make treatment more challenging. Researchers are interested in how long patients live after starting treatment, including chemotherapy drugs like Irinotecan, Fluorouracil, Calcium Folinate, and Oxaliplatin given before surgery. They'll compare this with patients who might only have surgery first. The main goal is to understand how these treatments affect survival and identify any factors that influence this.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz

Enrolment target

116

Start

28 Nov 2024

Resectable pancreatic adenocarcinoma with risk factors

What is this study about?

Imagine you or someone you know has been diagnosed with pancreatic cancer that doctors think they can remove with an operation. This study is specially designed for people in this situation who also have certain features that doctors call 'risk factors.' These risk factors might mean their cancer is a bit more challenging, even if surgery is possible. The main aim of this study is to look at how long people live after they start their treatment, whether that's chemotherapy first or surgery first. It helps doctors understand the real-world impact of these treatments over time.

Researchers are particularly interested in a type of treatment called 'neoadjuvant treatment.' This often involves chemotherapy drugs like Irinotecan, Fluorouracil, Calcium Folinate, and Oxaliplatin, which are given before surgery. The idea is to shrink the tumour or make surgery more effective. By studying patients who receive these treatments, doctors can gather important information about their effectiveness and safety in a broader group of people than in earlier studies.

Beyond how long people live, the study also looks at other important things. This includes how long people stay free from the cancer coming back, how many chemotherapy treatments they complete, how well they recover after surgery, and their overall quality of life. All this information helps doctors learn more about the best ways to treat this type of pancreatic cancer and give patients the best chance of a good outcome.

Key takeaways

This study focuses on real-world outcomes for pancreatic cancer patients.
It's for people with a specific type of pancreatic cancer that can be operated on but has 'risk factors'.
It investigates the impact of chemotherapy given before surgery.
The main goal is to understand how long patients live and how well they recover.
Participation helps improve care for future patients with pancreatic cancer.

Who may be eligible?

This study is open to adults aged 18 and over, of any gender. People who might be a good fit for this study have pancreatic cancer that doctors believe can be removed through surgery, but they also have certain features (called 'risk factors') that doctors will assess.

To be considered for this study, your doctor will check your specific cancer diagnosis and its characteristics. They will make sure it matches the type of pancreatic cancer the researchers are focusing on. You don't need to do anything specific to check your eligibility yourself, as your medical team will handle this detailed review.

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 doctors think can be removed by surgery?
Does your doctor say your cancer has certain 'risk factors'?
Are you able to attend regular follow-up appointments?
Are you open to either chemotherapy before surgery or surgery first, depending on your care plan?

Answer every question to see your result.

What does participation involve?

If you join this study, what happens next depends on the treatment path your doctors decide is best for you. Some patients might receive chemotherapy treatments for several cycles before surgery, while others might proceed directly to surgery. Regardless of the starting point, the study team will closely monitor your health.

This will involve planned visits to the clinic, usually to check how you're responding to treatment or recovering from surgery. You might have blood tests, scans, and your care team will ask you questions about how you're feeling and your quality of life. The treatments used are standard care, but the study helps gather more detailed information about them. The main part of participating involves regular follow-up appointments over a period of time to track your health and whether the cancer returns.

Potential risks and benefits

Taking part in this study may offer benefits, such as contributing to medical knowledge that could help future patients with pancreatic cancer. While the treatments used are standard care, your health will be closely monitored, which can be reassuring. As with any medical treatment, there are potential risks, including side effects from chemotherapy or complications from surgery. Your medical team will discuss all possible risks with you in detail. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is 'resectable pancreatic adenocarcinoma with risk factors'?

It means pancreatic cancer that doctors believe can be fully removed by surgery, but there are certain features that might make it a bit more challenging.

What does 'neoadjuvant treatment' mean?

This is treatment, like chemotherapy, given before surgery. The aim is often to shrink the tumour or make the surgery more successful.

What kind of drugs are being looked at?

The study focuses on common chemotherapy drugs like Irinotecan, Fluorouracil, Calcium Folinate, and Oxaliplatin, often given in combination.

What does 'overall survival' mean?

It's simply the length of time a patient lives after they start their treatment for the cancer.

Will I get different treatment than usual?

No, this study is looking at how well standard, approved treatments work in the real world for people like you. It's not testing new, unapproved drugs.