Active not recruitingPHASE2INTERVENTIONAL

A Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer

This study is for people with pancreatic cancer that has grown locally but hasn't spread to other parts of the body, and who haven't had treatment for it yet. Doctors want to see if adding a new drug, ATRA, to the usual treatment (gemcitabine and nab-paclitaxel) can improve outcomes. Patients taking part will be randomly put into one of two groups: one group gets the standard treatment, and the other gets the standard treatment plus ATRA. Both groups will receive treatment in cycles for a set period, or until the illness gets worse. The study will help doctors understand if this new combination could be a better way to treat this type of pancreatic cancer. It's important to note you can stop treatment at any time if you wish to.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Queen Mary University of London

Enrolment target

170

Start

30 Apr 2020

Estimated completion

28 Feb 2029

Pancreatic Cancer

What is this study about?

Pancreatic cancer can be a difficult illness to treat. Doctors are always looking for new and better ways to help patients.

This study is designed to investigate a treatment approach for pancreatic cancer that is considered 'locally advanced'. This means the cancer has grown into nearby areas but has not spread to other parts of the body. The aim is to see if adding an investigational drug called ATRA to two commonly used chemotherapy drugs, gemcitabine and nab-paclitaxel, can make the treatment more effective.

Patients taking part in this study will be randomly assigned to one of two groups. One group will receive the standard treatment which includes gemcitabine and nab-paclitaxel. The other group will receive the standard treatment plus ATRA. This is known as a "randomised trial," which is a common way for doctors to compare new treatments fairly against existing ones. These treatments will be given in monthly cycles. ATRA will be given for six cycles, while gemcitabine and nab-paclitaxel will continue until the doctor decides it's no longer benefiting you, or if you experience side effects that make it difficult to continue.

Key takeaways

This study is for locally advanced pancreatic cancer that hasn't been treated before.
It tests a new drug (ATRA) added to standard chemotherapy.
Patients are randomly assigned to one of two treatment groups.
Treatment involves monthly cycles, with regular hospital visits and check-ups.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you must have pancreatic cancer that is locally advanced and hasn't spread to other parts of the body. You also must not have received any previous treatment for your pancreatic cancer. Doctors will confirm this using scans like CT and PET-CT.

You need to be at least 16 years old, and there's no upper age limit. Your general health needs to be good enough to take part in the study, and doctors will check this by looking at your medical history and blood test results. These tests make sure your heart, kidneys, liver, and blood are working well enough to handle the treatments.

Before you can join, you'll need to read and sign a consent form, which explains everything about the study. This ensures you understand what's involved and agree to take part. Women who could become pregnant will need to take steps to avoid pregnancy during the study.

Quick self-check

I have pancreatic cancer that is locally advanced (hasn't spread far).
I have not had any previous treatment for my pancreatic cancer.
I am at least 16 years old.
My general health, including blood tests and organ function, is good enough for the treatments.
I am willing and able to read and sign a consent form.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a number of checks to make sure you're suitable for the study. Once you’re in, you’ll be randomly assigned to one of two treatment groups: one will receive a standard chemotherapy combination (gemcitabine and nab-paclitaxel), and the other will get the same chemotherapy plus the new drug, ATRA.

Your treatment will be given in cycles that last 28 days. ATRA, if you're in that group, will be given for six cycles (about six months). The other chemotherapy drugs will continue for longer, as long as they are helping you and you're not experiencing too many side effects. Throughout this time, you will have regular visits to the hospital for your treatment and to allow doctors and nurses to monitor how you are doing, check for any side effects, and see how the treatment is working. This will involve blood tests and other assessments. You can stop your involvement in the study at any time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A possible benefit is that the new drug combination might be more effective than standard treatment for your pancreatic cancer. However, this is not guaranteed, and the study is designed to find this out. There are also risks, as all medications can have side effects, and some people may experience unpleasant or serious reactions to the drugs. You will be closely monitored for any side effects, and the doctors will do their best to manage them. Importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Barts NHS Trust
London, United Kingdom

Common questions

What is 'locally advanced pancreatic cancer'?

This means the cancer has grown into tissues near the pancreas but has not spread to distant parts of the body, like the liver or lungs.

What does 'randomised' mean in this study?

It means you will be put into one of two treatment groups by chance, like flipping a coin. Neither you nor your doctor will get to choose which group you are in.

What is ATRA?

ATRA is a drug being tested to see if it can improve the effectiveness of standard chemotherapy for pancreatic cancer.

How long will the treatment last?

The ATRA part of the treatment typically lasts about six months. The other chemotherapy drugs will continue for as long as they are helping you and you are tolerating them well.

Can I stop participating in the study if I change my mind?

Yes, you can choose to stop your involvement in the study at any time, for any reason. Your decision will not affect your future medical care.