RecruitingPHASE2INTERVENTIONAL

Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

This study is testing a new treatment plan for pancreatic cancer that hasn't spread to other parts of the body but is too advanced for surgery. We want to see if giving two different types of strong chemotherapy, one after the other, can help. The first chemotherapy is called Gabrinox. After that, patients who are doing well will receive another chemotherapy called FOLFIRINOX. Finally, we'll see if adding a very precise type of radiation, guided by MRI scans, can further improve results for these patients. The goal is to find better ways to manage this challenging cancer and potentially make it easier to treat.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

103

Start

16 Jun 2021

Estimated completion

01 Jun 2030

Locally Advanced Pancreatic Adenocarcinoma

What is this study about?

This research study is focusing on a type of pancreatic cancer that doctors call 'locally advanced.' This means the cancer is still in or around the páncreas and hasn't spread to other organs like the liver or lungs. However, it's too big or in a difficult spot to be completely removed by surgery right away. Pancreatic cancer can be very challenging to treat, and doctors are constantly looking for more effective ways to help patients.

The main idea behind this study is to try a more intensive, two-step chemotherapy approach. First, patients will receive a combination of medicines known as Gabrinox. If their cancer responds well and doesn't get worse, they will then move on to a different, strong chemotherapy called FOLFIRINOX. The hope is that by using these powerful medications, we can shrink the cancer and better control its growth.

After the chemotherapy, for patients whose cancer hasn't progressed, the study will introduce a targeted radiation treatment called MRI-guided stereotactic radiotherapy. This is a very precise way to deliver radiation to the cancer cells while trying to protect healthy tissues nearby. By combining these treatments, researchers are hoping to find a better way to tackle locally advanced pancreatic cancer, potentially making it shrink more or even becoming removable by surgery in some cases, and ultimately aiming to improve how long people live after diagnosis.

Key takeaways

This study explores a new, intensive treatment plan for pancreatic cancer that can't be surgically removed yet.
It combines two strong chemotherapy regimens, Gabrinox and FOLFIRINOX, given one after the other.
For some patients, a precise form of radiation (MRI-guided radiotherapy) will follow chemotherapy.
The goal is to improve how well the cancer is controlled and potentially help people live longer.
Participation involves regular hospital visits for treatments, tests, and monitoring.
You have the right to withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 75 years old and have been diagnosed with pancreatic cancer that is confirmed as 'locally advanced.' This means the cancer is in the pancreas area but hasn't spread to other parts of your body, and it's not something that can be removed by surgery right now.

You also need to be well enough to take part, meaning you should be able to do your usual daily activities without too much trouble. Your blood tests, including checks on your blood counts, kidney function, and liver function, would need to be within healthy ranges to ensure you can safely receive the treatments. There are also specific levels for certain markers in your blood that would need to be checked.

The study also needs to confirm that the special radiation treatment, called SMART, is suitable for you after reviewing your scans. If you have a specific type of metal tube put in to help with bile flow, called a biliary prosthesis, your bilirubin levels (a check of liver health) need to have returned to normal after it was put in.

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 between 18 and 75 years old?
Has a doctor confirmed your pancreatic cancer is 'locally advanced' and not spread?
Are you generally well enough to do your daily activities?
Are your blood tests (like blood counts, liver, and kidney function) within healthy ranges?
Has a medical review confirmed that special radiotherapy is a suitable option for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening period where doctors run tests to make sure the study is right for you. This would involve blood tests, scans, and discussions about your health. If you qualify, you would then start the first course of chemotherapy, called Gabrinox. You'd receive this medication through a drip, likely over several weeks with breaks in between.

After completing Gabrinox, doctors would check how your cancer has responded. If it hasn't gotten worse, you would then move on to the second chemotherapy, FOLFIRINOX, which would also be given through a drip, probably over another period of weeks with breaks. Throughout these chemotherapy stages, you would have regular appointments, blood tests, and scans to monitor your health and how well the treatment is working.

For patients whose cancer is stable after chemotherapy, the study would then involve special MRI-guided radiation therapy sessions. This is a targeted treatment given over a shorter period. You would continue to have follow-up appointments, blood tests, and scans for a period after all treatments are finished to see the long-term effects. The total duration of active treatment and follow-up would depend on your individual response and the study plan.

Potential risks and benefits

Taking part in this study means you would receive intensive treatments which could potentially help shrink your cancer. However, all treatments for pancreatic cancer have side effects. Chemotherapy can cause tiredness, sickness, hair loss, and affect your blood counts. Radiation therapy can also have side effects, depending on the area treated. Doctors will monitor you closely for any unwanted effects and provide support. It's important to remember that joining a study doesn't guarantee a cure or improvement, but it could provide valuable information to help future patients. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting
CHU Carémeau
Verified postcode
Nîmes, France· Recruiting
CHU Saint-Eloi
Verified postcode
Montpellier, France· Recruiting
Institut régional du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
Hôpital Beaujon
Verified postcode
Clichy, France· Not yet recruiting
Centre Georges-François Leclerc
Verified postcode
Dijon, France· Recruiting
Hôpital Pitié Salpétriêre
Verified postcode
Paris, France· Recruiting
Centre Eugène Marquis
Verified postcode
Rennes, France· Not yet recruiting
Hopital Paul Brousse
Verified postcode
Villejuif, France· Not yet recruiting

Common questions

What does 'locally advanced' pancreatic cancer mean?

It means the cancer is in or near the pancreas and hasn't spread to other organs, but it's too difficult to remove with surgery right now.

What is chemotherapy and how will it be given?

Chemotherapy uses drugs to kill cancer cells. In this study, you'd receive two different types, Gabrinox and FOLFIRINOX, given through a drip.

What is MRI-guided stereotactic radiotherapy?

This is a very precise way to deliver radiation directly to the cancer using MRI scans to guide it, aiming to protect healthy tissue.

Will I have to stay in hospital?

While chemotherapy is usually given as an outpatient, you would have regular hospital visits for treatments and checks. In some cases you might stay overnight for severe side effects.

Are these treatments new?

The medicines themselves are established treatments, but this study combines them in a new sequence and with a special type of radiation, to see if this approach works better.

How to find out more

Aurore MOUSSION, MD

aurore.moussion@icm.unicancer.fr 0467612446 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.