Active not recruitingPHASE2INTERVENTIONAL

FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma

This research study is for people with locally advanced pancreatic cancer that hasn't spread to other parts of the body and can't be removed with surgery. It's investigating a new treatment called OncoSil™, which is given in addition to the standard chemotherapy, FOLFIRINOX. The main goal is to find out if adding OncoSil™ helps improve the treatment's safety and how well it works. Participants will either receive FOLFIRINOX alone or FOLFIRINOX with OncoSil™. Researchers will closely monitor patients for side effects, check how the treatment affects their cancer using scans, and assess their quality of life throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

OncoSil Medical Limited

Enrolment target

Start

26 Apr 2023

Estimated completion

01 Jul 2027

Locally Advanced Pancreatic Cancer

What is this study about?

This study is for individuals diagnosed with locally advanced pancreatic cancer. "Locally advanced" means the cancer is still contained within the area around the pancreas and hasn't spread to distant parts of the body, but it's not possible to remove it with surgery. The current standard treatment for this type of cancer often involves a strong chemotherapy combination called FOLFIRINOX.

Researchers are exploring a new approach by adding a treatment called OncoSil™ to FOLFIRINOX chemotherapy. OncoSil™ is a special device that delivers radiation directly to the tumour. The aim is to see if this combined treatment is more effective at shrinking the tumour and improving patient outcomes compared to FOLFIRINOX alone, while also understanding any additional side effects.

By taking part, you would be helping doctors learn more about the best ways to treat locally advanced pancreatic cancer. This type of research is crucial for developing new and better treatments for patients in the future.

Key takeaways

This study evaluates OncoSil™ alongside FOLFIRINOX chemotherapy for locally advanced pancreatic cancer.
It's for patients whose cancer cannot be surgically removed.
Participants will receive either standard chemotherapy or chemotherapy plus OncoSil™.
Regular monitoring, scans, and quality of life checks are part of the study.
The goal is to assess safety and effectiveness of the combined treatment.

Who may be eligible?

To join this study, you must have been diagnosed with pancreatic cancer that is locally advanced and cannot be surgically removed. Your tumour should also be less than 7cm across. You need to be at least 18 years old and generally well enough to start strong chemotherapy, meaning you have a good level of activity in your daily life.

Your blood tests for kidney, liver, and bone marrow function need to be within acceptable ranges, and you must not be pregnant. If you are a woman who could become pregnant, you'll need to use effective birth control throughout the study. You should also be able to understand the study and follow its procedures, and doctors must believe you have a life expectancy of at least three months.

Finally, you should be willing to receive regular treatment to protect your stomach during the study. Before you can definitely join, there will be a screening period to check all these details and ensure the study is right 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.

Do I have locally advanced pancreatic cancer that cannot be surgically removed?
Is my pancreatic tumour less than 7cm in size?
Am I at least 18 years old?
Am I generally well enough to start strong chemotherapy (e.g., active in daily life)?
Are my recent blood test results for kidneys, liver, and blood counts within normal or acceptable limits?
Am I willing to use effective birth control if I can become pregnant, or am I not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first go through a screening period for about three weeks to ensure the study is suitable for you. This will involve various tests, including a CT scan, to confirm your eligibility. Once eligible, you will be randomly assigned to one of two groups: either you will receive up to 12 cycles of the standard FOLFIRINOX chemotherapy, or you will receive the OncoSil™ treatment in addition to the same FOLFIRINOX chemotherapy.

Throughout the study, you'll have regular appointments every 4 to 8 weeks. These visits will involve discussions about any side effects you might be experiencing and how you are feeling generally. Every 8 weeks, you will have CT scans to check how the treatment is affecting your cancer. You'll also be asked to fill out questionnaires at different points to measure your quality of life. The total duration of your participation will depend on your individual treatment response and follow-up schedule.

Potential risks and benefits

Potential benefits of taking part could include receiving close medical attention and a new treatment (OncoSil™) that might improve outcomes for your pancreatic cancer. However, there's no guarantee that the new treatment will work for everyone, and it might not be more effective than standard treatment. All treatments, including FOLFIRINOX and OncoSil™, come with potential side effects, which the medical team will discuss with you. You will be closely monitored for any reactions. It's very important to remember that participating in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

Royal Adelaide Hospital
Verified postcode
Adelaide, Australia
AZ Maria Middelares
Verified postcode
Ghent, Belgium
San Camillo Forlanini
Verified postcode
Rome, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verified postcode
Verona, Italy
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Verified postcode
Madrid, Spain
Hospital Universitario 12 de Octobre
Verified postcode
Madrid, Spain
Hospital Universitario de Fuenlabrada
Verified postcode
Madrid, Spain
Hospital Universitario Ramón y Cajal
Verified postcode
Madrid, Spain
Clínica Universidad de Navarra
Verified postcode
Pamplona, Spain
Guy's Hospital
Verified postcode
London, United Kingdom
The Christie Hospital/Manchester Royal Infirmary
Verified postcode
Manchester, United Kingdom

Common questions

What is FOLFIRINOX?

FOLFIRINOX is a combination of several different chemotherapy drugs used to treat certain cancers, including pancreatic cancer.

What is OncoSil™?

OncoSil™ is a device designed to deliver a type of radiation directly into the tumour in the pancreas.

What does 'locally advanced' mean for pancreatic cancer?

It means the cancer is still in the area around the pancreas and hasn't spread to other parts of the body, but it can't be removed by surgery.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of two groups – either standard chemotherapy alone or chemotherapy plus OncoSil™ – which allows for a fair comparison. This is called 'randomisation'.

How long will I be in the study?

The study will involve regular visits and assessments, and the full length of your participation will depend on your treatment and how closely you need to be followed up.