Not yet recruitingOBSERVATIONAL

Survival Without Persistent Limiting Toxicity: Real Life Prospective Cohort of Advanced Neuroendocrine Tumor

This study, called TOLERATE, is for people in the UK with advanced neuroendocrine tumors. These are rare cancers that often allow people to live for many years. Doctors want to understand how different treatments affect patients over a long time, especially looking at side effects that might limit their daily life. There are many treatment options, but it's not always clear which order works best to keep people feeling well. This research will track patients in real-world settings, using questionnaires and remote monitoring, to see which treatment paths lead to the best quality of life without long-lasting, difficult side effects. The goal is to create a tool that helps doctors choose the kind of treatment or treatment sequence that has the lowest risk of causing ongoing, bothersome side effects for each individual patient.

At a glance

Status

Not yet recruiting

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

1,100

Start

01 Jun 2026

Estimated completion

01 Jun 2034

Neuroendocrine (NE) Tumors

What is this study about?

Imagine you have a rare type of cancer called a neuroendocrine tumor (NET) that has spread or can't be removed with surgery. These cancers are often slow-growing, meaning people can live with them for many years. While this is good news, it also means that over time, you might receive several different treatments. Doctors want to know how these treatments, especially when used one after another, affect your overall health and well-being in the long run.

This study, named TOLERATE, is designed to understand this better. It's not testing a new drug, but rather observing what currently happens in real life for people receiving standard care. The main goal is to find out which treatment approaches, or sequences of treatments, allow people to live longer and feel better, without experiencing too many long-lasting and difficult side effects. It's about finding the balance between effective treatment and maintaining a good quality of life.

To do this, the study will follow a large group of patients with advanced NETs over several years. They will collect information about the treatments patients receive, and critically, how these treatments affect their daily lives through surveys and questionnaires. This will help doctors understand common side effects that can limit everyday activities and how long these side effects last. The information gathered will help create a tool to guide treatment decisions, aiming for the best possible outcomes for future patients.

Key takeaways

Aims to improve treatment for advanced neuroendocrine tumors.
Observes real-world treatment experiences, no experimental drugs.
Focuses on long-term side effects and quality of life.
Involves regular surveys and questionnaires from home.
Helps develop better treatment guidance for future patients.
Your medical care will not change if you participate.

Who may be eligible?

This study is looking for adults aged 18 or over who have been recently diagnosed (within the last 6 months) with a particular type of advanced neuroendocrine tumor. This means the cancer has either spread (metastatic) or cannot be removed by surgery (unresectable).

Your neuroendocrine tumor needs to be of a specific type that is 'well-differentiated' and confirmed by pathology tests. You also need to be a patient already receiving your care for this advanced neuroendocrine tumor at an expert centre within the French ENDOCAN network, where your treatment decisions are made by a team of specialists following established guidelines.

Finally, to join the study, you shouldn't have any major health issues that would make taking part unsafe for you, and you must agree to your information being collected and to participate in the study's surveys.

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?
Have you been diagnosed with an advanced neuroendocrine tumor (that has spread or can't be removed with surgery) in the last 6 months?
Is your care managed by an expert centre in the French ENDOCAN network?
Are you willing to complete monthly surveys and questionnaires about your health and treatment effects?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the TOLERATE study, your medical care will remain exactly the same as it would be if you weren't in the study. This study doesn't involve any new medicines or procedures; it's focused on gathering information about your real-world experience.

You will be asked to complete monthly surveys online or by phone about any side effects you might be experiencing from your cancer or its treatments. These surveys will help the researchers understand how these affect your daily life. Additionally, you'll be asked to fill out more detailed questionnaires about your quality of life at the beginning of the study, every six months, and one month after you start any new treatment. These questionnaires might include questions about how you're feeling, your symptoms, and a pedometer to track your activity.

The study will follow you until you reach a certain outcome (like a significant side effect or a change in your health), your care ends, or for up to five years, whichever comes first. This remote monitoring and questionnaire approach means fewer extra clinic visits for you.

Potential risks and benefits

A potential benefit of joining this study is that you would be contributing valuable information that could help future patients with neuroendocrine tumors. By sharing your experiences, you'll help doctors understand which treatment paths lead to the best long-term outcomes with fewer limiting side effects, and improve decision-making tools for others. There are very few direct risks to you as this study does not involve new treatments or change your medical care; the main time commitment is completing questionnaires. You will not be exposed to any experimental drugs. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (14)

CHU Caen
Verified postcode
Caen, France
CHU Clermont Ferrand
Verified postcode
Clermont-Ferrand, France
APHP Beaujon
Verified postcode
Clichy, France
CHU Dijon
Verified postcode
Dijon, France
CHU Lille
Verified postcode
Lille, France
Hôpital Edouard Herriot
Verified postcode
Lyon, France
APHM Marseille La Timone
Verified postcode
Marseille, France
APHP Cochin
Verified postcode
Paris, France
CHU Poitiers
Verified postcode
Poitiers, France
CHU Reims
Verified postcode
Reims, France
Centre Eugene Maquis
Verified postcode
Rennes, France
CHU Strasbourg
Verified postcode
Strasbourg, France

Common questions

What is a neuroendocrine tumor?

It's a rare type of cancer that starts in cells that are like nerve cells and hormone-producing cells. They can develop in many different parts of the body.

Will I get new medicines in this study?

No, this study doesn't involve giving you any new medicines. It observes the treatments you are already receiving as part of your normal care.

How much extra time will this study take up?

You'll need to complete a short online or phone survey each month about your side effects, and more detailed quality of life questionnaires every six months and after starting a new treatment.

What does 'limiting toxicity' mean?

It refers to side effects from treatment that are bothersome or severe enough to really affect your daily activities and how you feel.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care or relationship with your doctors.

How to find out more

Eric Baudin, Dr

eric.baudin@gustaveroussy.fr +33142114242 Official trial record

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