RecruitingPHASE2INTERVENTIONAL

A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours

This study is investigating a treatment called Lutetium-177 Octreotate (Lu-DOTA-TATE) for a type of slow-growing cancer known as neuroendocrine tumours (NETs). NETs are often diagnosed late, so treatments like this are important. This specific type of treatment, sometimes called Lutathera®, is already used in many places. However, in Alberta, Canada, where this study is happening, it's not publicly funded. The study aims to confirm how well Lu-DOTA-TATE works, if it's safe, and how it impacts patients' quality of life and how long they live. Patients will be split into two groups: those new to the treatment and those who have received it before. The hope is to gather more evidence to support wider access to this treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

500

Start

29 Apr 2014

Estimated completion

01 Dec 2042

Carcinoma, Neuroendocrine

What is this study about?

This study is looking at a specific treatment called Lutetium-177 Octreotate, sometimes known as Lu-DOTA-TATE, for people who have certain types of cancer called neuroendocrine tumours (NETs). NETs are not very common, and they tend to grow slowly. Often, they are only found when they have spread to other parts of the body. This treatment uses a radioactive substance to target and treat these cancer cells. In some parts of the world, a version of this treatment, called Lutathera®, is already approved and used, but it's not always easy for everyone to get.

Researchers have been using this type of treatment for many years with good results in some patients. However, they've been asked by health authorities to conduct a formal study to gather stronger evidence. The main goals of this study are threefold: first, to see how well the Lu-DOTA-TATE treatment works for NETs that have specific markers (called somatostatin receptors); second, to check if the treatment is safe and what side effects it might have; and third, to understand how this treatment affects patients' daily lives and their long-term health.

By carefully studying a group of patients, researchers hope to get a clearer picture of the benefits and any potential drawbacks of this treatment. This information could then help more people with neuroendocrine tumours get access to this particular therapy in the future, improving their care and quality of life.

Key takeaways

Investigates a targeted treatment for neuroendocrine tumours.
Aims to check safety, effectiveness, and impact on quality of life.
Includes patients new to treatment and those continuing it.
Involves multiple treatments and long-term follow-up.
Could help make this treatment more widely available in the future.

Who may be eligible?

To be considered for this study, you would generally need to be between 14 and 90 years old and have a confirmed diagnosis of a neuroendocrine tumour. Importantly, your tumour needs to show certain markers, called somatostatin receptors, which doctors can check with special scans. You would also need to show that your cancer has been growing or spreading, or that your symptoms are not well controlled by other treatments.

There are also some important health checks you'd need to pass to make sure the treatment is safe for you. This includes having healthy kidney and liver function, and good blood counts. If you've had this treatment before under a special program, you might be able to continue receiving it as part of this study. Otherwise, you'd be new to the treatment.

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 between 14 and 90 years old?
Do you have a confirmed diagnosis of a neuroendocrine tumour?
Do your tumour cells show specific markers on scans?
Is your cancer actively growing or are your symptoms not well controlled?
Do you have generally healthy kidney and liver function and blood counts?

Answer every question to see your result.

What does participation involve?

If you join this study, you might be in one of two groups. If you haven't had this treatment before (Group A), you would typically receive up to four treatments, spaced 10 to 14 weeks apart. Before and during each treatment, you'll receive a special liquid to protect your kidneys. After these initial treatments, if your cancer is stable or improving and you haven't had major side effects, you might be able to continue with more treatments, up to a maximum of eight. You'll have regular check-ups and scans throughout this time to see how the treatment is working and monitor your health.

If you have already received this treatment before through a special program (Group B), you would continue with your regular treatment schedule within the study. Everyone in the study will have follow-up appointments for six months and one year after their last treatment to check on their progress. After that, you'll have yearly check-ups for up to five years to see how you're doing in the long term. This helps researchers understand the full impact of the treatment over time.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a treatment that has shown promise in helping manage neuroendocrine tumours, potentially improving your quality of life and survival. However, like all medical treatments, there are potential risks and side effects that will be explained to you in detail by the study team. You'll be closely monitored for any issues throughout the study. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What are neuroendocrine tumours (NETs)?

NETs are rare, often slow-growing cancers that can start in different parts of the body. They can sometimes produce hormones, leading to various symptoms.

What is Lutetium-177 Octreotate treatment?

It's a special type of treatment that uses a radioactive substance to target and kill cancer cells that have specific markers on their surface.

How long will I be in the study?

Treatment can involve multiple doses over several months, followed by follow-up appointments for up to five years to monitor your health.

Will this treatment cure my cancer?

This study aims to assess how effective the treatment is at managing NETs, improving quality of life, and extending survival, but it doesn't guarantee a cure.

Will I have to pay for the treatment?

Clinical trials typically cover the cost of the study treatment itself. You should discuss all financial aspects with the study team.

How to find out more

NET Coordinator

acb.neuroendocrine@ahs.ca 780-577-8080 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.