Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients
This study is looking at advanced bowel cancer that has spread to other parts of the body. It compares two different treatment combinations: FOLFIRINOX plus Panitumumab versus mFOLFOX6 plus Panitumumab. These treatments include chemotherapy drugs and a 'targeted' drug called Panitumumab. The study is for people whose cancer has specific genetic markers (RAS and B-RAF wild-type), which means their cancer may respond better to targeted treatments like Panitumumab. The main goal is to see how many patients experience a complete response to the FOLFIRINOX and Panitumumab combination. Researchers will also look at how long people live, how long they stay free from cancer progression, and if the treatments can shrink tumours enough for surgery. It's a national study across several hospitals.
At a glance
What is this study about?
This study is for people in the UK who have bowel cancer that has spread to other parts of the body, also known as metastatic colorectal cancer. At the moment, doctors know that some bowel cancers respond better to certain treatments than others, depending on their genetic make-up. This study is specifically looking at cancers that do not have changes (mutations) in the RAS and B-RAF genes, often called 'wild-type' for these genes. This specific genetic information is important because it helps doctors decide if a drug like Panitumumab is likely to work.
The study aims to compare two different ways of treating this specific type of advanced bowel cancer. Both treatments use the drug Panitumumab, which is a 'targeted therapy' that works by blocking signals that cancer cells use to grow. This is combined with different chemotherapy regimens: one group will receive FOLFIRINOX (a combination of fluorouracil, folinic acid, irinotecan, and oxaliplatin), and the other group will receive mFOLFOX6 (a combination of fluorouracil, folinic acid, and oxaliplatin). By comparing these two drug combinations, researchers hope to find out which one is more effective at treating the cancer.
The main thing the researchers want to find out is whether the FOLFIRINOX and Panitumumab combination can lead to a *complete response* in more patients. A complete response means all signs of cancer disappear. They will also be looking at overall survival (how long people live), progression-free survival (how long people live without their cancer getting worse), how much the tumours shrink, and the safety of the treatments.
Key takeaways
- Compares two drug combinations for advanced bowel cancer.
- For cancers with specific genetic makeup (RAS/B-RAF wild-type).
- Aims to find which treatment leads to best response and survival.
- Panitumumab is a 'targeted' drug.
- Involves regular hospital visits, treatments and scans.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would need to be between 18 and 75 years old and generally well enough to manage daily activities without much difficulty. You must have bowel cancer that has spread and doctors believe it cannot be cured with surgery alone. Your cancer also needs to have a specific genetic profile, meaning it should not have mutations in the RAS and B-RAF genes, which will be checked using a blood test.
You would not be able to join if you’ve had another type of cancer in the last five years (unless it was a very early-stage skin or cervical cancer), or if you’ve already been treated for your advanced bowel cancer. Similarly, if you’ve had certain chemotherapy drugs (like oxaliplatin) as an 'adjuvant' treatment after initial surgery, or if you have cancer that has spread to your brain, this study might not be suitable. Certain other health conditions, past serious allergic reactions to the study drugs, or if you are receiving other treatments that could interfere with the study drugs would also prevent you from taking part.
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?
- Do you have advanced bowel cancer that has spread?
- Has your doctor confirmed your cancer is 'RAS and B-RAF wild-type'?
- Have you NOT had previous treatment for your advanced bowel cancer?
- Do you not have cancer spread to the brain?
- Are you generally well and active?
What does participation involve?
If you join this study, you will be randomly assigned to one of two treatment groups, meaning a computer will decide which drug combination you receive. Most of the treatments involve infusions (drips) that you receive in the hospital. You will have regular visits to the hospital for your treatment sessions and to monitor your health. This will include blood tests, scans (like CT scans) to check how your cancer is responding, and physical examinations. The doctors and nurses will also ask you about any side effects you might be experiencing. The overall duration of your participation will depend on how you respond to the treatment and the study plan, but you will continue to be monitored regularly. You will also have follow-up appointments even after treatment finishes, to track your long-term health and cancer status.
Potential risks and benefits
Locations (6)
- Institut Sainte CatherineVerified postcodeAvignon, France
- Centre Léon BerardVerified postcodeLyon, France
- Chu Saint EloiVerified postcodeMontpellier, France
- ICM Val D'AurelleVerified postcodeMontpellier, France
- Institut de Cancérologie de LorraineVerified postcodeNancy, France
- CHU Carémeau - Institut de Cancérologie du GardVerified postcodeNîmes, France
Common questions
What kind of bowel cancer is this study for?
This study is for advanced bowel cancer that has spread to other parts of the body (metastatic) and has specific gene features (RAS and B-RAF wild-type).
What are the two treatments being compared?
The study compares FOLFIRINOX plus Panitumumab against mFOLFOX6 plus Panitumumab. Both include chemotherapy and a targeted drug called Panitumumab.
Why is genetic testing important for this study?
Knowing your cancer's genetic features (RAS and B-RAF) helps doctors understand if the targeted drug Panitumumab is likely to be an effective treatment for you.
What is a 'complete response'?
A complete response means that all signs of the cancer that could be seen on scans or tests have disappeared.
Can I choose which treatment I receive?
No, if you join the study, you will be randomly assigned to one of the two treatment groups, like flipping a coin.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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