RecruitingPHASE2INTERVENTIONAL

Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

This study, called FIRE-8, is investigating new ways to treat bowel cancer that has spread to other parts of the body (metastatic colorectal cancer). It's a Phase 2 trial, meaning it's still in the earlier stages of testing. Researchers want to compare two different treatment combinations. One group of patients will receive a drug called trifluridine/tipiracil alongside panitumumab. The other group will receive trifluridine/tipiracil alongside bevacizumab. By comparing these two approaches, the study aims to understand which combination is more effective at treating this type of cancer in patients who are not suitable for or prefer not to have intensive chemotherapy. Patients will be randomly assigned to one of these two treatment groups.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Dominik Paul Modest

Enrolment target

153

Start

17 Dec 2021

Estimated completion

01 Dec 2032

Metastatic Colorectal Cancer

What is this study about?

This study, called FIRE-8, is looking into new treatment options for bowel cancer that has spread to other parts of the body. When cancer spreads, it's known as 'metastatic'. The main goal of this research is to see if one particular combination of medicines works better than another as the very first treatment for this condition.

The study will compare two different groups of patients. Both groups will receive a medicine called trifluridine/tipiracil. However, one group will also receive panitumumab, while the other group will receive bevacizumab. These are different types of targeted therapies that work in specific ways to fight cancer cells. The researchers will be carefully monitoring how well each combination works to shrink tumours or stop them from growing.

This is a 'Phase 2' study, which means it's still relatively early in the testing process. The information gathered will help doctors understand which of these treatment strategies might be more effective and safer for patients with metastatic colorectal cancer, particularly for those who might not be suitable for, or choose not to have, more traditional chemotherapy combinations.

Key takeaways

Compares two different medicine combinations for advanced bowel cancer.
Aims to find the most effective first-line treatment for metastatic colorectal cancer.
Involves the drugs trifluridine/tipiracil, panitumumab, and bevacizumab.
For patients where standard combination chemotherapy isn't suitable or preferred.
Requires a specific 'RAS wild-type' gene status in the tumour.
Participation includes close medical monitoring and regular check-ups.

Who may be eligible?

To join this study, you must be at least 18 years old and have bowel cancer that has spread. You'll need to have had a recent scan showing measurable areas of cancer, and your doctors will need to confirm that surgery to remove the spread hasn't been possible or isn't wanted.

An important point is that your cancer cells must have a specific genetic feature called 'RAS wild-type'. This is determined by a special test. Also, your doctors will need to agree that standard combination chemotherapy isn't the best option for you, or you may simply prefer not to have it. You'll also need to be generally well enough to take part, as assessed by your medical team, and certain blood and kidney tests must show you have good organ function.

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 at least 18 years old?
Do you have bowel cancer that has spread?
Has a doctor confirmed that you cannot or prefer not to have intensive chemotherapy?
Has your cancer been tested and confirmed as 'RAS wild-type'?
Are your general health and organ functions (like liver, kidneys, blood) within certain acceptable limits?
Do you have cancer that can be measured on scans?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves hasn't been provided in the brief summary. However, generally, in studies like this, you would have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is working. You would receive one of the two medicine combinations. There would also be follow-up appointments after the main treatment phase. The total length of your participation would be explained by the study team.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could be more effective than existing ones, though this isn't guaranteed. You'll also be closely monitored by a medical team. However, there are potential risks, as all medications can have side effects. These will be fully explained to you before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What type of cancer is this study for?

This study is for bowel cancer (colorectal cancer) that has spread to other parts of the body.

What medicines are being tested?

The study is testing two combinations: trifluridine/tipiracil plus panitumumab, and trifluridine/tipiracil plus bevacizumab.

Why are these specific medicines important?

These are targeted therapies and chemotherapy that work in specific ways to fight cancer cells. The study aims to find out which combination works best as a first treatment.

Will I know which treatment I'm getting?

Yes, this is an 'open label' study, meaning both you and your doctor will know which treatment you are receiving.

Is this study for everyone with bowel cancer?

No, there are specific requirements, such as your cancer having a 'RAS wild-type' gene, and your doctor agreeing that intensive chemotherapy isn't the right option for you.

How to find out more

Dominik Paul Modest, Prof.

dominik.modest@charite.de +49 30 450 553840 Official trial record

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