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High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

This international study is exploring different treatments for high-risk neuroblastoma, a serious cancer that affects children and young people. Researchers want to find the best way to combine chemotherapy (medication to kill cancer cells) and radiotherapy (using radiation to destroy cancer cells). They are comparing various treatment plans, including different strengths and combinations of chemotherapy before and after surgery, and carefully targeted radiation. The main goal is to see which approaches help patients live longer without their cancer returning. This study involves several stages, with patients being randomly assigned to different treatment groups to fairly compare their effectiveness. The findings will help doctors improve care for children with high-risk neuroblastoma.

Em resumo

Status
Recrutamento
Fase
FASE3
Patrocinador
Gustave Roussy, Campus do Câncer, Grande Paris
Meta de inscrição
800
Iniciar
05 Nov 2019
Conclusão estimada
01 Nov 2032

Sobre o que é este estudo?

This important international study is focused on improving treatment for children and young people diagnosed with a serious type of cancer called high-risk neuroblastoma. Doctors are always looking for better ways to fight cancer, and this study aims to find the most effective combinations of treatments.

Specifically, the researchers are comparing different approaches to chemotherapy and radiotherapy. Chemotherapy uses powerful medicines to kill cancer cells, while radiotherapy uses targeted radiation. The study involves several steps, where patients will be randomly assigned to different treatment groups. For example, some groups might receive different types of chemotherapy first. Later, after surgery, some might get different amounts or types of radiation, especially if some cancer remains.

The main goal is to discover which of these treatment plans works best to help patients stay well and prevent the cancer from coming back. By carefully comparing these different methods, doctors hope to develop new, more effective standard treatments for high-risk neuroblastoma, giving children and young people a better chance at long-term health.

Pontos principais

  • This is an international study focusing on high-risk neuroblastoma.
  • It compares different chemotherapy and radiotherapy plans.
  • The goal is to find the most effective treatments to improve patient outcomes.
  • Patients are randomly assigned to different treatment groups.
  • It aims to reduce cancer recurrence and improve long-term survival.

Quem pode ser elegível?

This study is looking for children and young people who have been diagnosed with high-risk neuroblastoma, usually before they've started much treatment. This might include those with a widespread form of the cancer, or those with a specific genetic change in their cancer cells (called MYCN amplification).

If you've already started some chemotherapy, you might still be able to join, especially if it was a very early treatment for an emergency situation or for a more localized cancer. Generally, participants should be diagnosed with neuroblastoma according to specific international guidelines.

Girls and young women who might become pregnant will need to take a pregnancy test and agree to use effective contraception during the study and for a year afterwards.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Have you been diagnosed with high-risk neuroblastoma?
  2. Are you a child or young person up to 21 years old?
  3. Have you had little to no previous chemotherapy for your cancer?
  4. Are girls and young women able to take a pregnancy test and use birth control if needed?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

Taking part in this study means you would follow a specific treatment plan that involves different types of chemotherapy and potentially radiotherapy. These treatments are given at specialist hospitals. You would have regular visits to the hospital for your treatments, check-ups, and tests to see how you are responding. The doctors will monitor you closely throughout the treatment period.

Because this study compares different treatment approaches, participants will be randomly chosen for one of several groups. This ensures a fair comparison. The total duration of your participation would involve the treatment period itself, followed by ongoing check-ups for several years to track your long-term health and the cancer's status.

Riscos e benefícios potenciais

Participating in this study might offer the benefit of receiving potentially more effective and advanced treatments for high-risk neuroblastoma. You would also be closely monitored by a team of experts. However, all treatments for cancer carry potential risks and side effects, and some of the treatments being tested might be more intense than standard care. You would be fully informed about all possible side effects before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (142)

  • Sydney children Hospital
    Código postal verificado
    Sydney, Austrália· Recrutamento
  • Children's Cancer Centre, Monash Children's Hospital
    Código postal verificado
    Clayton, Austrália· Recrutamento
  • Oncology/Haematology Department, Perth Children's Hospital
    Código postal verificado
    Nedlands, Austrália· Suspended
  • Children's Cancer & Haematology Services, John Hunter Children's Hospital
    Código postal verificado
    New Lambton Heights, Australia· Recrutamento
  • Australian and New Zealand Children's Hematology/oncology Group
    Código postal verificado
    Sydney, Austrália· Ativo, mas não recrutando
  • sydney children Hospital
    Código postal verificado
    Sydney, Austrália· Recrutamento
  • Cancer Centre for Children, The Children's Hospital
    Código postal verificado
    Westmead, Australia· Suspended
  • Medical University Graz
    Código postal verificado
    Graz, Áustria· Recrutamento
  • Landeskrankenhaus-Universitätsklinikum Innsbruck
    Código postal verificado
    Innsbruck, Áustria· Recrutamento
  • Kepler Universitatsklinikum Linz
    Código postal verificado
    Linz, Austria· Recrutamento
  • Universitastsklinikum Salzburg
    Código postal verificado
    Salzburgo, Áustria· Recrutamento
  • St Anna'S Children Hospital
    Código postal verificado
    Viena, Áustria· Recrutamento

Perguntas frequentes

What is high-risk neuroblastoma?

It's a serious type of cancer that develops from nerve cells and mostly affects young children. 'High-risk' means it often needs intensive treatment.

What does 'randomized' mean in a study?

It means patients are put into different treatment groups by chance, like flipping a coin. This helps doctors fairly compare which treatment works best.

O que é quimioterapia?

Chemotherapy is medicine used to kill cancer cells or stop them from growing.

What is radiotherapy?

Radiotherapy uses targeted rays, similar to X-rays, to destroy cancer cells in a specific area of the body.

Posso parar de participar se mudar de ideia?

Yes, you can choose to leave the study at any time, for any reason. Your medical care will not be affected.

Como saber mais

Claudia Pasqualini, MD PhD

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

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