AuthorisedTherapeutic confirmatory (Phase III)Interventional

Prospective multicenter clinical trial for risk estimation and treatment stratification in low and intermediate risk neuroblastoma patients - NB2015-LR

This important study is for children diagnosed with 'low' or 'intermediate risk' neuroblastoma, a type of cancer that usually affects very young children. The main goal is to find out which treatments work best for these groups, to improve their chances of getting well and staying well. Researchers will look at how long children stay free from the disease after treatment, and also how long they live overall. They will compare different treatment plans, including some that might be less intense. The study also aims to understand why some children respond better to treatment than others and to track any side effects from the medicines, ensuring children receive the most effective and safest care possible.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Of Cologne

Enrolment target

280

Start

25 Oct 2024

low and intermediate risk neuroblastoma

What is this study about?

This study, called NB2015-LR, is looking into neuroblastoma, which is a type of cancer that mostly affects babies and young children. When a child is diagnosed with neuroblastoma, doctors try to figure out how serious it is, often described as 'low risk' or 'intermediate risk'. This study is specifically for children in these risk groups.

The main aim of this research is to discover the most effective treatments for children with low and intermediate risk neuroblastoma. Doctors want to ensure that children receive enough treatment to cure the cancer, but not more than they need, to reduce side effects. They're particularly interested in how long children stay healthy after treatment, checking if the cancer comes back or if new problems arise. They also want to understand what makes some treatments work better for certain children than others.

By carefully studying the effects of different medicines and treatment plans, including how some children might respond to a less intense treatment, and by looking at any side effects, the researchers hope to improve the care for all children with neuroblastoma. This research is a 'Phase III' study, which means it's a large, in-depth study designed to confirm the best treatment approaches.

Key takeaways

A study for children with low or intermediate risk neuroblastoma.
Aims to find the best and safest treatments.
Compares different treatment types to improve outcomes.
Checks how long children stay well after treatment.
Monitors for potential side effects from medications.
Helps to understand why some treatments work better than others.

Who may be eligible?

This study is open to both boys and girls who have been diagnosed with neuroblastoma that doctors have classified as 'low risk' or 'intermediate risk'.

Children of any age, from birth up to 18 years old, can potentially take part. Doctors will carefully check other aspects of a child's health and their specific cancer details to make sure the trial is right for them.

Quick self-check

Is your child diagnosed with neuroblastoma?
Has their neuroblastoma been classified as 'low' or 'intermediate risk'?
Is your child 18 years old or younger?
Are you happy for your child to receive different medical treatments as part of the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, doctors will keep a close eye on their health and how they respond to treatment. This will involve regular visits to the hospital for check-ups, tests, and to receive their medicines. The specific medicines your child receives will depend on the treatment group they are in. The study will track how well the treatments work and any side effects your child might experience. The total duration of your child's participation will depend on their treatment plan and how long they need follow-up care, which will be discussed fully with you.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of receiving a new or carefully managed treatment for your child's neuroblastoma. The information we gather will also help other children in the future. However, all medical treatments have potential side effects, and the medicines used in this study are known to cause some. Your child's care team will monitor them closely for any issues. You are free to withdraw your child from the study at any time, for any reason, and this will not affect their ongoing medical care.

Locations (1)

—
Germany

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that develops from immature nerve cells found in several areas of the body, most commonly the adrenal glands near the kidneys.

What does 'low or intermediate risk' mean?

This describes how likely the cancer is to be severe. Low or intermediate risk means the cancer is less aggressive and generally has a better chance of being successfully treated.

Will my child definitely get a new treatment?

Not necessarily. The study compares different approaches, which might include standard treatments, reduced treatments, or combinations of medicines to find the best option for children in your child's risk group.

What kind of side effects might my child experience?

Chemotherapy medicines can cause side effects like feeling sick, tiredness, hair loss, and changes to blood counts. Your doctors and nurses will explain these fully and manage them carefully.

How long will my child be in the study?

The length of time depends on the specific treatment plan your child receives and how often they need follow-up appointments. This will be explained in detail before you decide to take part.