Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomized phase II study of PAnitumumab REchallenge followed by REgorafenib versus the reverse sequence in RAS and BRAF wild-type chemorefractory metastatic colorectal cancer patients. The PARERE trial

This research study, called PARERE, is for people with advanced bowel cancer that has spread to other parts of the body. We are looking at two existing medicines, panitumumab (Vectibix) and regorafenib (Stivarga), and trying to find the best order to give them. Patients will be split into two groups: one group will get panitumumab first, followed by regorafenib, and the other group will get them in the reverse order. We want to see which sequence helps patients live longer, which is our main goal. We'll also be closely monitoring how well the treatments work, if the cancer grows, and any side effects people might experience. This study is for people whose cancer has certain genetic features (called 'RAS and BRAF wild-type') and has already been treated with other medicines.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione GONO G.I.

Enrolment target

214

Start

16 Sep 2024

Colorectal cancer spread at distance, RAS BRAF wild type pretreatted

What is this study about?

This study, called PARERE, is focused on finding the best way to treat advanced bowel cancer (also known as colorectal cancer) that has spread to other parts of the body. For some people, standard treatments might stop working, and that's when studies like this become very important. We are comparing two medicines, panitumumab (brand name Vectibix) and regorafenib (brand name Stivarga), which are already approved for use. The main question we want to answer is whether receiving these two medicines in a particular order makes a difference to how long people live.

Imagine you have two good tools, but you're not sure which one to use first to get the best result. That's a bit like what we're doing here. One group of patients will receive panitumumab first, and then if their cancer progresses, they will switch to regorafenib. The other group will do the opposite, starting with regorafenib and then switching to panitumumab. By doing this, we hope to learn which sequence is more effective and whether one order leads to fewer side effects or better control of the cancer.

The main thing we are measuring is 'Overall Survival', which simply means how long patients live after starting the study. We also look at other important things like how well the treatment shrinks or controls the cancer, how long it takes for the cancer to start growing again, and what side effects people experience. The information we gather will help doctors understand how to best use these medicines for future patients with similar types of advanced bowel cancer.

Key takeaways

This study compares two existing bowel cancer drugs given in different sequences.
It's for advanced bowel cancer that has specific genetic markers and is no longer responding to previous treatments.
The main aim is to see if one treatment order helps patients live longer.
Patients will receive panitumumab (Vectibix) and regorafenib (Stivarga), one after the other.
Side effects and cancer progression will be carefully monitored.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically for adults aged 18 or over. It is designed for both men and women.

To be considered for this study, you must have advanced bowel cancer that has spread to other parts of your body. Also, your cancer needs to have certain genetic features, described by doctors as 'RAS and BRAF wild-type'. This means your cancer cells don't have particular changes in these specific genes.

Importantly, you must have already received other treatments for your bowel cancer, and unfortunately, these treatments are no longer keeping the cancer under control. The research team will do tests to confirm that you meet all these requirements before you can join the study.

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?
Do you have advanced bowel cancer that has spread?
Has your doctor confirmed your cancer has the 'RAS and BRAF wild-type' genetic features?
Have you already had other treatments for your bowel cancer that are no longer working?
Are you able to take medicines by mouth (tablets) and receive infusions (through a vein)?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will be randomly assigned to one of two treatment groups, like flipping a coin, so neither you nor your doctor can choose which group you are in. You will either start with panitumumab (Vectibix) given by infusion (into a vein) or regorafenib (Stivarga) taken as tablets by mouth. If your cancer grows or your first treatment is no longer effective, you will then switch to the other medicine. This process will continue as long as the treatment is helping you and you are managing any side effects.

Throughout the study, you will have regular visits to the clinic for medical check-ups. These visits will include blood tests, physical examinations, and scans (like CT or MRI) to see how the cancer is responding and to monitor for any side effects. These scans will happen about every 8 weeks to track your progress. The medical team will also keep a close eye on any side effects you might experience, ranging from mild to more serious ones. You will be part of the study for as long as the treatment is beneficial and tolerable for you, with regular follow-up appointments.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving close medical attention and access to medicines that might help control your cancer. However, there's no guarantee that the treatments will be effective for everyone, and your cancer might not respond to the medications. Like all medicines, panitumumab and regorafenib can cause side effects. These can range from mild to serious, and the study team will monitor you closely for them. You will be fully informed about all known risks before you decide to join. Remember, taking part in this study is completely voluntary, and you are free to withdraw at any time, for any reason, without it affecting your usual 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
Italy

Common questions

What kind of cancer is this study for?

This study is for advanced bowel (colorectal) cancer that has spread to other parts of the body and has specific genetic features (RAS and BRAF wild-type).

What medicines are being used in this study?

The study uses two medicines called panitumumab (Vectibix) and regorafenib (Stivarga).

What is the main goal of the study?

The main goal is to find out if giving these two medicines in a certain order helps people with advanced bowel cancer live longer.

Will I get to choose which medicine I start with?

No, you will be randomly assigned to one of the two treatment groups, like choosing by chance.

What if the treatment isn't working for me?

If your first treatment isn't working or the cancer grows, you will switch to the other medicine within the study.