Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
This research study, called COMPOSE, is investigating a treatment called Lutetium-177 (177Lu-Edotreotide), which is a type of targeted radiation therapy, for certain advanced neuroendocrine tumours affecting the gut or pancreas. These are specific types of cancer that are aggressive and well-differentiated (meaning the cells still look somewhat like healthy cells). The study aims to see if this new treatment, given as a first or second treatment option, is better or safer than current standard treatments. Researchers will also look at how patients feel and their quality of life during and after the treatment. This will help doctors understand if Lutetium-177 could be a better choice for patients with these specific cancers.
At a glance
What is this study about?
This study, known as COMPOSE, is focused on a particular type of cancer called a neuroendocrine tumour (NET). These tumours can develop in different parts of the body, but this study specifically looks at those in the gut (gastroenteric) or pancreas. These aren't like common cancers; they can be quite aggressive, even though the cells still look somewhat organised under a microscope (this is what "well-differentiated" means).
The main goal of the study is to test a treatment called Lutetium-177 (177Lu-Edotreotide). This is a special type of radiation therapy, but unlike traditional radiotherapy, it's very targeted. It uses a small amount of radioactive material that attaches specifically to certain cells on the neuroendocrine tumours. This helps deliver the radiation directly to the cancer cells while trying to spare healthy tissues. The study wants to find out if this targeted radiation is more effective at treating these tumours, safer for patients, and helps people feel better compared to the standard treatments doctors currently use.
Researchers will compare Lutetium-177 with what your doctor might normally suggest, such as chemotherapy drugs like CAPTEM (Capecitabine and Temozolomide) or FOLFOX (Folinic acid, Fluorouracil, and Oxaliplatin), or other treatments like Everolimus. By comparing these, the study hopes to understand if Lutetium-177 could become a better option for people with these specific kinds of aggressive neuroendocrine tumours in the future. The results will help doctors make more informed decisions about the best way to treat patients.
Key takeaways
- Tests a new targeted radiation called Lutetium-177 for aggressive neuroendocrine tumours.
- Compares it to standard treatments for gut and pancreas NETs.
- Aims to see if it's more effective, safer, and improves quality of life.
- Participation involves regular clinic visits, tests, and questionnaires.
- You might receive the new treatment or a standard one, decided by chance.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. You need to have a specific type of neuroendocrine tumour that started in your gut or pancreas. These tumours must be "well-differentiated" (meaning the cells often still look a bit like normal cells) and have certain 'markers' (called somatostatin receptors) that the study drug can attach to. Your doctor will need to confirm this with scans and tissue samples.
There are also some reasons why you might not be able to join. For example, if you have allergies to any of the study medications or similar drugs. If you've had a similar type of targeted radiation treatment before, or major surgery recently, you might not be eligible. If you're pregnant or breastfeeding, or if you have other serious health problems with your kidneys, liver, heart, or blood that could make the treatments unsafe, you also won't be able to participate.
The research team will carry out several tests to ensure this study is safe and right for you. It's important that you can understand the information about the study and agree to take part freely.
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 a well-differentiated neuroendocrine tumour of the gut or pancreas?
- Has your tumour been confirmed to have 'somatostatin receptors' (SSTR+)?
- Have you NOT had a similar type of targeted radiation treatment before?
- Are you NOT pregnant or breastfeeding?
- Do you NOT have serious problems with your kidneys, liver, heart, or blood?
What does participation involve?
If you decide to take part in this study, you will either receive the new targeted radiation treatment (Lutetium-177) or one of the standard treatments for your type of cancer. The specific treatment you receive will be decided by chance, like flipping a coin. You won't know which treatment you're getting beforehand, and neither will your doctor.
Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and scans (like CT or MRI). These are to monitor how you're responding to the treatment and to check for any side effects. You'll also be asked to fill out questionnaires about how you're feeling and your quality of life. The exact number of visits and tests will depend on which treatment you receive and how your body responds. The study will involve a treatment period, followed by ongoing monitoring to see the long-term effects. The total length of your participation will vary, but it will involve regular follow-up for a significant period to track your health.
Potential risks and benefits
Locations (42)
- Stanford Cancer CenterVerified postcodePalo Alto, United States
- University of Colorado Hospital, Nuclear MedicineVerified postcodeAurora, United States
- H. Lee Moffitt Cancer Center & Research InstituteVerified postcodeTampa, United States
- Dana Farber Cancer InstituteVerified postcodeBoston, United States
- Mayo Clinic - Rochester, Department of OncologyVerified postcodeRochester, United States
- Washington University Alvin J. Siteman Cancer CenterVerified postcodeSt Louis, United States
- Memorial Sloan-Kettering Cancer CenterVerified postcodeNew York, United States
- ICAHN School of Medicine at Mount Sinai, Tish Cancer InstituteVerified postcodeNew York, United States
- Duke University School of Medicine, Duke Cancer InstituteVerified postcodeDurham, United States
- Oregon Health and Science UniversityVerified postcodePortland, United States
- Fox Chase Cancer CenterVerified postcodePhiladelphia, United States
- Texas OncologyVerified postcodeDallas, United States
Common questions
What are neuroendocrine tumours?
They are a less common type of cancer that can develop in cells throughout the body, including the gut and pancreas, often producing hormones.
What is targeted radiation therapy?
It's a treatment that uses a small amount of radioactive material designed to stick to cancer cells, delivering radiation directly to the tumour while trying to protect healthy parts of the body.
Will I know which treatment I'm getting?
No, the treatment you receive (either the new targeted radiation or standard care) is chosen by chance, and neither you nor your doctor will know which one you're getting.
How long will I be in the study?
The study involves a period of treatment and then long-term monitoring, so the total time will vary depending on your individual response and the study's follow-up plan.
What if I change my mind about participating?
You are free to leave the study at any time, for any reason, and this will not affect your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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