Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

FFCD 1605- OPTIPRIME: A phase II study evaluating FOLFOX + panitumumab according to a ‘stop-and-go’ strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment, as the first line in patients with metastatic colorectal adenocarcinoma without a RAS mutation

This study is investigating a new treatment plan for people with advanced bowel cancer that has spread to other parts of the body. This particular type of bowel cancer does not have a specific gene change called a RAS mutation. The treatment involves a combination of established chemotherapy drugs (FOLFOX, including Xeloda, Folinic acid, Eloxatine, and Fluorouracile Teva) and a targeted drug called panitumumab (Vectibix). The study uses a 'stop-and-go' strategy, meaning treatment might be paused and restarted depending on how the cancer responds. It's a Phase II study, which means researchers are checking how well the treatment works and if it's safe. The main goal is to find out how long the cancer can be kept under control with this new approach.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondation Franc.Cancerologie Digestive

Enrolment target

118

Start

13 Nov 2024

metastatic colorectal adenocarcinoma

What is this study about?

This study is called OPTIPRIME and it’s looking at a new way to treat advanced bowel cancer (also known as colorectal adenocarcinoma) that has spread to other parts of the body. This treatment is specifically for patients whose cancer does not have a particular abnormal gene change, called a RAS mutation. This information is important because certain treatments work better for cancers without this mutation.

The treatment being tested combines several drugs you might already be familiar with or have heard of: FOLFOX (which includes drugs like oxaliplatin, fluorouracil, and folinic acid) and a targeted drug called panitumumab (Vectibix). What’s new is how these drugs are given. The study is using a 'stop-and-go' approach. This means you might receive a period of active treatment, then a break where you only receive a milder maintenance drug (fluoropyrimidine), and if the cancer starts to grow again, the full treatment might be restarted. The idea is to find out if this 'stop-and-go' method can keep the cancer under control for longer, while potentially reducing side effects during the breaks.

This is a Phase II study, which means the researchers are mainly focused on understanding how well the treatment works to control the cancer and whether it's safe for patients. They will be carefully measuring how long the cancer stays under control (which they call 'disease control duration') and also looking at other things like how much the tumours shrink, how long people live, their quality of life, and any side effects.

Key takeaways

This study evaluates a new treatment strategy for advanced bowel cancer without a RAS mutation.
It combines standard chemotherapy (FOLFOX) with a targeted drug (panitumumab).
The treatment plan uses a 'stop-and-go' approach to control the cancer.
The main goal is to see how long the cancer remains under control.
It's a Phase II study, focusing on effectiveness and safety.
Participants must be adults aged 18 or over.

Who may be eligible?

This study is looking for adult patients who have bowel cancer that has spread to other parts of the body. Importantly, their cancer should not have a specific gene change called a RAS mutation, as this type of treatment is designed for cancers without this mutation.

Patients taking part can be male or female, and must be at least 18 years old. There's no upper age limit, meaning older adults can also be considered for this study.

Before joining, you'll have specific tests to confirm your diagnosis and check your overall health to make sure this study is right for you. Your medical team will guide you through this process.

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 bowel cancer that has spread?
Has your doctor confirmed that your cancer *does not* have a RAS mutation?
Are you willing and able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the exact details will be discussed with you by your medical team. Generally, taking part would involve regular visits to the hospital or clinic. During these visits, you would receive the study medications, which include a combination of chemotherapy drugs given by infusion (into a vein) and possibly daily tablets, along with regular infusions of panitumumab. You would also have blood tests, scans (like CT scans), and physical exams to check how you are responding to the treatment and to monitor for any side effects.

The study uses a 'stop-and-go' plan. This means you might have a period of intensive treatment, followed by a break where you might receive a less intense medication to keep the cancer stable. If the cancer starts to grow again during this break, the more intensive treatment might be reintroduced. The total length of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially effective treatment approach for your specific type of bowel cancer. This might help to control your cancer for longer. However, like all medical treatments, there are potential risks and side effects from the drugs used. Your doctor will discuss all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
France
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Unverified
Belgium

Common questions

What is 'metastatic colorectal adenocarcinoma'?

This is a medical term for bowel cancer that has started in the colon or rectum and has spread to other parts of the body.

What does 'RAS-mutation negative' mean?

This refers to bowel cancer cells that do not have a specific change in their genes called a 'RAS mutation'. This is important because certain treatments, like panitumumab in this study, are more likely to work when this mutation isn't present.

What is a 'stop-and-go' strategy?

This is a treatment approach where you might have intensive chemotherapy for a while, then switch to a milder maintenance treatment, and then restart the intensive treatment if needed. The aim is to balance effectiveness with reducing side effects.

What is a Phase II study?

A Phase II study is a stage of clinical research where doctors are trying to find out if a new treatment works well and is safe in a larger group of people. It builds on earlier safety checks.

Will I get a placebo (dummy treatment)?

No, this study does not involve a placebo. All participants will receive active treatment using the specific drug combinations and treatment strategy being tested.