A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer
This study is for women with advanced or returning womb (endometrial) cancer. After finishing chemotherapy, some patients will receive a new drug called Selinexor, while others will get a dummy pill (placebo). This is to see if Selinexor can help stop the cancer from growing back or getting worse for a longer time. Doctors will carefully monitor how the cancer responds and if patients experience any side effects. The study also looks at how life quality changes. This is a Phase 3 trial, meaning it's a critical step in testing if this new treatment could be a useful option for patients in the future.
At a glance
What is this study about?
This clinical trial is designed for women who have advanced or recurrent endometrial cancer, which is a type of cancer that starts in the lining of the womb. It's looking into a new treatment called Selinexor. Patients in this study have already had chemotherapy, and this trial aims to see if continuing with Selinexor afterwards can help keep the cancer under control for longer.
After their chemotherapy, participants will be randomly chosen to receive either Selinexor tablets or a placebo, which looks just like Selinexor but contains no active drug. This is done so researchers can fairly compare the effects of Selinexor against not having the active drug. Neither the patient nor their doctor will know whether they are receiving Selinexor or the placebo, which helps make the results as accurate as possible.
The main goal is to find out if Selinexor can increase the time patients live without their cancer growing or getting worse. The study will also track things like overall survival, how patients' general health and well-being change, and any side effects from the treatment. This type of study, called a Phase 3 trial, is a very important step to see if Selinexor could become a standard treatment option for this type of cancer in the future.
Key takeaways
- This study investigates Selinexor for advanced or recurrent womb cancer after chemotherapy.
- It aims to see if Selinexor helps keep cancer from growing for longer.
- Patients will receive either Selinexor or a dummy pill (placebo).
- It's a Phase 3 study, a key step to potentially making Selinexor a new treatment option.
- The study will monitor cancer growth, side effects, and quality of life.
- Participation involves regular clinic visits for checks, scans, and blood tests.
Who may be eligible?
This study is specifically for women who are 18 years old or older. You must have advanced or recurrent endometrial cancer, meaning your cancer has spread or has come back after previous treatment.
Before you can join, your medical team will need to confirm that you meet all the specific health requirements for the study. This includes checking your past medical history, current health, and how well your body systems are working, such as your kidneys and liver. They will also look at your recent treatment history.
- Are you 18 years old or over?
- Have you been diagnosed with advanced or recurrent endometrial cancer?
- Have you already completed chemotherapy treatment?
- Are you fit enough to take part in a clinical trial and attend regular appointments?
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 will first undergo a series of checks to make sure you're suitable. Once enrolled, you will be given either Selinexor tablets or a placebo to take by mouth. You will be asked to attend regular clinic visits for blood tests, physical examinations, and scans to monitor your health and how your cancer is responding. You will also be asked to complete questionnaires about your quality of life.
Throughout the study, the medical team will keep a close eye on any side effects you might experience. The total duration of your participation would depend on how long the treatment works for you and as long as you tolerate the medication well. Follow-up reviews will happen even after stopping the study treatment to continue monitoring your health.
Potential risks and benefits
Locations (6)
- —Italy
- —Germany
- —Belgium
- —Greece
- —Czechia
- —Spain
Common questions
What is endometrial cancer?
Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). It's one of the most common gynaecological cancers.
What does 'advanced or recurrent' mean?
Advanced means the cancer has spread beyond its original site. Recurrent means the cancer has come back after it was successfully treated before.
What is a placebo?
A placebo is a dummy pill that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the new treatment with no active treatment.
What does a 'Phase 3 trial' mean?
Phase 3 is a late stage of clinical trial. It means the treatment has already shown promise in earlier studies, and this trial is designed to confirm if it's safe and effective, and better than existing options.
How long will I be on the treatment?
You will continue to take the study treatment for as long as it is helping to control your cancer and you are tolerating it well, or until the study concludes, whichever comes first.
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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