PRODIGE 51 - GASTFOX: Phase III randomised trial evaluating FOLFOX with or without DOCETAXEL (TFOX) as 1st line chemotherapy for locally advanced or metastatic oesophago-gastric adenocarcinoma
This research, called PRODIGE 51 - GASTFOX, is a clinical trial for adults with stomach or gullet (oesophageal) cancer that has spread or is advanced locally. Doctors are trying to find the best way to treat this cancer. The study compares a standard chemotherapy mix (FOLFOX, which includes three drugs: fluorouracil, oxaliplatin, and calcium levofolinate) with a slightly different mix that adds a fourth drug called docetaxel (TFOX). The main goal is to see if adding docetaxel helps people live longer without their cancer getting worse, specifically looking at how things are 12 months after starting treatment. Researchers will also look at how long people live overall. This study helps doctors understand if the new drug combination is more effective for patients.
At a glance
What is this study about?
This study, known as PRODIGE 51 - GASTFOX, is for people who have advanced stomach or gullet (oesophageal) cancer. This means the cancer has spread to other parts of the body (metastatic) or is extensively grown in the area it started (locally advanced). When cancer reaches this stage, treatments aim to control the cancer, improve symptoms, and help people live longer.
Currently, a common way to treat this type of cancer is with a combination of chemotherapy drugs called FOLFOX. This study is testing whether adding another chemotherapy drug, docetaxel, to the FOLFOX mix (creating a new combination called TFOX) works better. The researchers want to find out if this new combination can keep the cancer from growing for a longer time compared to the standard FOLFOX treatment.
Understanding which treatment works best is really important for doctors and patients. By comparing these two treatment approaches, the study hopes to find out if the new combination offers a significant benefit. This could potentially lead to a new standard treatment option for people with advanced stomach or gullet cancer in the future, offering them a better chance at managing their condition.
Key takeaways
- This study is for adults with advanced stomach or gullet cancer.
- It compares a new chemotherapy combination (TFOX) with a standard one (FOLFOX).
- The main goal is to see if TFOX helps control cancer for longer.
- Participation involves regular hospital visits for treatment and checks.
- You'll be randomly assigned to one of the two treatment groups.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults who have been diagnosed with advanced stomach or gullet (oesophageal) cancer. This means your cancer has either spread to other parts of your body or is growing extensively in the area it started.
Both men and women can take part in this research. You need to be at least 18 years old to be considered for the study. There is no upper age limit for participation.
When considering if this study is right for you, your doctors will also look at other health factors to ensure that the treatment in the study would be safe and appropriate for your specific situation. This involves detailed medical checks to make sure you fit all the necessary criteria.
- Are you 18 years old or older?
- Have you been diagnosed with advanced stomach or gullet cancer?
- Are you considered well enough by your doctor to receive chemotherapy?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you not currently pregnant or breastfeeding (if applicable)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be assigned by chance (like flipping a coin) to receive one of two chemotherapy treatments: either the standard FOLFOX combination or the TFOX combination (which includes an extra drug, docetaxel). Both treatments are given through your veins.
You would have regular visits to the hospital for your chemotherapy sessions and check-ups. These visits would involve things like blood tests, physical examinations, and scans to see how the treatment is working and to monitor your health. The doctors and nurses would carefully track any side effects you might experience.
The treatment would continue for a certain period, and then you would have follow-up appointments to continue monitoring your health and how your cancer is doing. The total duration of your involvement could vary, but the main goal is to assess what happens 12 months after the last person joins the study, and your doctors will keep checking on you even after your treatment phase is finished.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is advanced oesophago-gastric adenocarcinoma?
This is a type of cancer that starts in the stomach or gullet (oesophagus) and has either spread to other parts of the body or is growing extensively where it started.
What is chemotherapy?
Chemotherapy uses powerful drugs to kill cancer cells or slow their growth. It's given through your veins, typically in cycles, with breaks in between.
What does 'randomised' mean in this study?
It means you will be assigned by chance, like drawing lots, to receive one of the two treatment groups. Neither you nor your doctor can choose which treatment you get.
What is 'progression-free survival'?
This refers to the length of time during and after treatment that you live without your cancer growing or getting worse.
Will I have to pay to be part of the study?
No, your participation in the study and the treatments provided as part of the study would be free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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