A phase II randomized trial, non comparative, evaluating chemotherapy associated cisplatin, 5-fluorouracil and docetaxel at adapted doses in patients with locally advanced squamous cell carcinoma
This research is investigating chemotherapy treatments for a type of cancer called locally advanced squamous cell carcinoma, which often appears in the head or neck area and hasn't yet spread to distant parts of the body. The study is comparing different combinations of common chemotherapy drugs like cisplatin, 5-fluorouracil, and docetaxel, given at adjusted doses. Researchers want to see how successful these treatments are after eight weeks. They are also looking at how long people live, how long they stay free from cancer progression, if their voice box (larynx) can be saved, and their overall quality of life during treatment. The aim is to find the most effective and tolerable ways to treat this cancer.
At a glance
What is this study about?
This study is a type of clinical trial called a Phase II trial. This means it's one of the earlier stages of testing new treatments, building on safety information learned in previous phases. Its main goal is to find out if certain chemotherapy combinations are effective and safe enough to be studied in larger trials.
The specific cancer being looked at here is 'locally advanced squamous cell carcinoma.' This is a common type of cancer, often found in parts of the head and neck, such as the mouth, throat, or voice box. 'Locally advanced' means the cancer has grown into nearby tissues or lymph nodes but has not yet spread to distant parts of the body. This trial is testing combinations of well-known chemotherapy drugs: cisplatin, 5-fluorouracil, and docetaxel. These drugs are already used to treat various cancers, but this study is trying them in new combinations or at adjusted doses for this specific type of cancer.
The researchers will measure how many patients have a successful outcome after eight weeks of treatment. They will also track how long people live, how long they remain free of cancer progression, whether they can keep their voice box (larynx), if the cancer spreads elsewhere, and if treatment causes unwanted side effects that might lead to a hospital stay. A very important aspect of the study is also looking at patients' quality of life, using special questionnaires to understand how the treatment affects their daily lives.
Key takeaways
- This study is for locally advanced squamous cell carcinoma (often head or neck cancer).
- It's testing different combinations of standard chemotherapy drugs.
- The main goal is to see how successful treatment is after 8 weeks.
- Researchers will also track survival, cancer progression, and quality of life.
- Paticipation involves treatments, tests, and completing questionnaires.
- You can stop participating at any time.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. Both men and women can participate. The main requirement is that you have been diagnosed with locally advanced squamous cell carcinoma – this is a specific type of cancer, often found in the head and neck, that has grown into nearby areas but hasn't spread to distant parts of the body.
There will be other detailed medical checks to make sure the treatment is safe for you and that the study results are clear. For example, doctors will need to check your overall health, other medical conditions you might have, and any other medications you are taking. These checks help ensure that participation is as safe as possible for everyone involved.
- Are you at least 18 years old?
- Have you been diagnosed with locally advanced squamous cell carcinoma?
- Does your doctor agree this study might be suitable for you?
- Are you able to attend regular hospital or clinic visits?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would receive the chemotherapy drugs being tested, likely through infusions. The study involves several visits to the hospital or clinic for these treatments and for check-ups. During these visits, doctors will perform examinations, take blood tests, and do scans to see how you are responding to the treatment and to monitor for any side effects.
You will also be asked to complete questionnaires about your quality of life. The study measures success at 8 weeks, but follow-up will continue for a longer period to track your overall health, how long you stay free from cancer, and overall survival. The total duration of your participation will depend on your individual response and the follow-up schedule, but typically involves regular check-ups for several months or even years after initial treatment.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is 'locally advanced squamous cell carcinoma'?
It's a common type of cancer, often in the head or neck, that has grown into nearby tissues or lymph nodes but hasn't spread to distant parts of the body.
What are 'Phase II' clinical trials?
These are early-stage trials that test if a new treatment or combination of treatments is effective and safe enough to be studied in larger groups of people.
What chemotherapy drugs are being used?
The study is looking at combinations of cisplatin, 5-fluorouracil, and docetaxel, which are well-known cancer medications.
Will I have to stay in the hospital?
Chemotherapy is often given during hospital visits, and sometimes side effects might require a longer hospital stay. The study will monitor this closely.
What does 'quality of life' mean in this study?
It means how the treatment affects your daily life, your feelings, and your overall well-being. You'll answer questionnaires about this.
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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