Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
This study is for people in the UK with advanced, slow-growing neuroendocrine tumours (NETs) in their midgut that can't be removed by surgery. These are NETs rated as Grade 1 or 2. The study uses a treatment called 177Lu-Dotatate, which is a type of targeted radiotherapy. The main goal is to find out if giving this treatment less often (every 16 weeks instead of every 8 weeks) can reduce serious side effects, particularly those affecting blood cells. Researchers also want to check if the less frequent treatment is still just as effective at controlling the tumour. By potentially reducing side effects, this approach could improve the quality of life for patients undergoing this therapy.
At a glance
What is this study about?
This clinical trial is designed for people in the UK with a specific type of cancer called neuroendocrine tumours (NETs) that are found in the middle part of the gut. These tumours are described as 'advanced' (meaning they may have spread) and 'slowly progressive' (meaning they are growing slowly). The tumours also need to be 'well-differentiated' and either Grade 1 or Grade 2, which helps doctors understand their behaviour. Patients are considered for this study if their tumours cannot be removed by surgery or if they have spread to other parts of the body.
The study focuses on a treatment called 177Lu-Dotatate. This is a special type of targeted radiotherapy. It works by attaching to specific cells in the NETs and delivering radiation directly to the tumour, aiming to shrink it or stop it from growing. The main question this research wants to answer is whether giving this treatment less frequently – every 16 weeks instead of the usual 8 weeks – can reduce difficult side effects, especially those that affect the blood. Reducing these side effects could make the treatment easier to manage for patients.
At the same time, the researchers need to ensure that the less frequent treatment is just as good at controlling the cancer. They will be carefully comparing the size of the tumours, how long they stay under control, and how long people live, between the two treatment schedules. The ultimate goal is to find a treatment approach that is both effective against the cancer and kinder to the patient's body, potentially improving their overall experience and quality of life during treatment.
Key takeaways
- New study for advanced, slow-growing midgut NETs (Grade 1-2).
- Compares two schedules for 177Lu-Dotatate treatment: every 8 weeks vs. every 16 weeks.
- Main goal: check if less frequent treatment causes fewer serious side effects, especially blood problems.
- Also, important to ensure the less frequent treatment is still just as effective against the cancer.
- Participation involves regular hospital visits for treatment and health checks.
- Aim is to improve patient quality of life by finding a more manageable treatment plan.
Who may be eligible?
This study is looking for adults aged 18 or over. You might be able to take part if you have a specific type of advanced neuroendocrine tumour (NET) in your midgut that has been growing slowly. Your tumour needs to be 'Grade 1' or 'Grade 2' and shown to have certain markers on its surface, which doctors can check with a special scan. It also needs to be a tumour that cannot be removed surgically or has already spread. You also must not have received this specific type of radiotherapy treatment (177Lu-Dotatate) before.
To be eligible, your general health needs to be good enough to undergo the treatments. This means your blood counts, kidney function, and liver function need to be within a healthy range, as confirmed by blood tests. You also need to be generally active and able to look after yourself, as measured by a specific health score (Karnofsky performance status).
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 aged 18 or older?
- Do you have advanced, slow-growing NETs in your midgut (Grade 1 or 2)?
- Have your tumours been checked to have specific markers on their surface?
- Have you NOT had this specific 177Lu-Dotatate radiotherapy treatment before?
- Is your general health, including blood, kidney, and liver function, good enough for treatment?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups. One group will receive the 177Lu-Dotatate treatment every 8 weeks, and the other group will receive it every 16 weeks. In both groups, you'll have four cycles of treatment in total. The treatment itself is given as a drip into a vein over about 30 minutes, and during the infusion, you'll also receive an amino acid solution. You might also be on other standard medications like Lanreotide or Octreotide.
Throughout the study, you'll have regular hospital visits for assessments. These will involve blood tests to check your blood counts and organ function, scans (like CT or MRI) to see how the tumour is responding, and assessments of your general health and any side effects you might be experiencing. The overall time you will be actively receiving treatment and being closely monitored will be over several months, with follow-up appointments continuing for some time after the last treatment to track your progress and long-term health. The study will keep track of your health for at least 24 months from the start of treatment.
Potential risks and benefits
Locations (21)
- Centre François BACLESSEVerified postcodeCaen, France· Not yet recruiting
- Chu DijonVerified postcodeDijon, France· Not yet recruiting
- Hospital Center University De LilleVerified postcodeLille, France· Not yet recruiting
- Hospices civiles de LyonVerified postcodeLyon, France· Not yet recruiting
- Institut Paoli CalmetteVerified postcodeMarseille, France· Not yet recruiting
- Hopital BEAUJONVerified postcodeClichy, France· Not yet recruiting
- Hopital COCHINVerified postcodeParis, France· Not yet recruiting
- Centre Eugène MARQUISVerified postcodeRennes, France· Not yet recruiting
- Hospital Universitario de BurgosApproximateBurgos, Spain· Recruiting
- Hospital Universitari Vall d'HebrónVerified postcodeBarcelona, Spain· Recruiting
- Instituto Catalán de Oncología - Hospital Duran i ReynalsVerified postcodeL'Hospitalet de Llobregat, Spain· Recruiting
- Hospital Virgen de las Nieves de GranadaVerified postcodeGranada, Spain· Recruiting
Common questions
What are neuroendocrine tumours (NETs)?
NETs are rare types of cancer that can develop in cells throughout the body, including the gut. Our study focuses on those in the 'midgut'.
What does 'Grade 1-2' mean?
This refers to how quickly the tumour cells are dividing and growing. Grade 1 and 2 tumours are generally slow to moderately growing.
What is 177Lu-Dotatate?
It's a targeted radiotherapy treatment. It uses a small amount of radiation attached to a substance that finds and attaches to specific NET cells, delivering treatment directly to them.
What are the main differences between the two treatment groups?
Both groups receive the same medicine, 177Lu-Dotatate. The only difference is how often it's given: one group gets it every 8 weeks, and the other every 16 weeks.
Will this treatment cure my cancer?
While treatments like 177Lu-Dotatate can be very effective in controlling neuroendocrine tumours, clinical trials aim to improve treatment and understanding, not necessarily guarantee a cure. Your doctor can discuss your specific prognosis.
How to find out more
A responsible person designated by the sponsor
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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