Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
This study is for people in France who have a specific type of gut cancer called neuroendocrine tumour (NET) that has started to grow again after already having four doses of a treatment called Lutathera. Researchers want to compare two extra doses of Lutathera with careful monitoring (watching the cancer closely) in these patients. The main goal is to find out if these additional doses are effective in controlling the cancer's growth. Lutathera is a treatment that targets cancer cells directly. This trial will help doctors understand the best way to use Lutathera for patients whose cancer comes back after initial treatment.
At a glance
What is this study about?
Imagine your body has tiny messengers called hormones, and sometimes, cells that make these messengers can grow too much and form a type of cancer called a neuroendocrine tumour (NET). Specifically, this study focuses on NETs that start in the gut and are growing again after previous treatment.
You might have already had a special treatment called Lutathera, which uses a small amount of radiation to target and kill these cancer cells. Patients often have four cycles of this treatment, and it's been shown to be very helpful in slowing down the cancer's growth and improving quality of life. However, even after successful treatment, the cancer can sometimes start to grow again.
Doctors in France can offer more Lutathera if the cancer progresses, but they're not sure how many extra cycles are best. Some doctors give two extra cycles, while others might give more. This study wants to find out if giving two additional cycles of Lutathera is more effective at stopping the cancer from growing further compared to simply monitoring the cancer closely without more treatment, for patients who have already had two extra cycles after their first recurrence.
Key takeaways
- The study investigates more Lutathera treatment for gut NETs that grow again.
- It compares two extra Lutathera doses versus close monitoring.
- Participants have already had initial Lutathera and experienced cancer progression.
- Aims to find the best way to retreat with Lutathera for recurring cancer.
- Focuses on safety and effectiveness of additional Lutathera cycles.
- This research can help improve care for people with this type of cancer.
Who may be eligible?
This study is looking for adults aged 18 or older who have a specific type of gut neuroendocrine tumour that has been confirmed by tests. You must have already completed four cycles of Lutathera treatment in the past, and your cancer should have been stable for at least 12 months after that first treatment.
Now, your cancer must be showing signs of growing again (this could be from scans or other tests). The decision to consider more Lutathera treatment must have been discussed and approved by a specialist cancer team. You need to be generally well enough to participate, with a good outlook for your health for at least the next six months.
Your cancer cells must also show up clearly on special scans that look for certain markers (like Gallium-68 or Indium-111 scans). You must have cancer that can be measured on regular scans, and your blood tests for bone marrow health (like haemoglobin, white blood cells, and platelets) need to be within a healthy range. If you are a woman who could become pregnant, you'll need a negative pregnancy test and to use effective contraception during and for six months after the study.
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 18 years old or older?
- Do you have an intestinal neuroendocrine tumour?
- Have you already completed four cycles of Lutathera treatment?
- Has your cancer started to grow again after your initial Lutathera treatment?
- Are your general health and blood test results within a healthy range?
- Can you attend all required hospital visits and assessments?
What does participation involve?
If you join this study, you will either receive two extra doses of Lutathera or be carefully monitored, depending on which group you are assigned to. The Lutathera doses are typically given every eight weeks. This study builds on current practices where you would have already received at least two additional cycles of Lutathera after your initial four cycles. You will have regular doctor's visits, blood tests, and scans to check how your cancer is responding and to monitor for any side effects. The total duration of your participation will depend on how your cancer responds to treatment and how long the study needs to follow your progress.
Potential risks and benefits
Locations (28)
- Institut de Cancérologie de l'Ouest Site d'AngersVerified postcodeAngers, France· Recruiting
- Institut BergoniéVerified postcodeBordeaux, France· Recruiting
- CHRU MorvanVerified postcodeBrest, France· Recruiting
- Hospices civils de LYON - GHEVerified postcodeBron, France· Recruiting
- Centre François BaclesseVerified postcodeCaen, France· Recruiting
- CH Métropole de SavoieVerified postcodeChambéry, France· Recruiting
- Centre Jean PerrinVerified postcodeClermont-Ferrand, France· Recruiting
- Hopital BeaujonVerified postcodeClichy, France· Recruiting
- CHU de DIJONVerified postcodeDijon, France· Recruiting
- CHU Grenoble Alpes (CHUGA)Verified postcodeLa Tronche, France· Recruiting
- CHRU LilleVerified postcodeLille, France· Recruiting
- Centre léon bérardVerified postcodeLyon, France· Recruiting
Common questions
What is Lutathera?
Lutathera is a special treatment that uses a mild radioactive substance to target and kill specific cancer cells in your body.
Why is this study only for people in France?
This study is starting in France because of specific rules about how Lutathera is used and covered by healthcare there.
Will I definitely get more Lutathera if I join?
Not necessarily. You will be put into one of two groups: one receiving more Lutathera, and one where doctors will carefully watch your cancer without more treatment at that time.
What are neuroendocrine tumours?
These are a type of cancer that starts in cells that are like nerve cells and hormone-producing cells. They can occur in many places, including the gut.
What does 'progressive disease' mean?
It means your cancer has started to grow or spread again since your last treatment.
How to find out more
Moussion Aurore, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.