This clinical trial focuses on studying neuroblastoma, a type of cancer that most commonly affects children. The trial aims to improve the survival of patients with low and intermediate risk neuroblastoma by using a variety of treatments. The treatments being studied include several medications: Melphalan, Dinutuximab Beta, Filgrastim, Vindesine Sulfate, Vincristine Sulfate, Busulfan, Cyclophosphamide, Etoposide, Carboplatin, Dacarbazine, Ifosfamide, Cisplatin, Clonazepam, Lenograstim, Mesna, Doxorubicin Hydrochloride, and Etoposide Phosphate. These medications are used in different forms such as infusions or injections, and some are specifically designed to protect the bladder or support the immune system.
The purpose of the study is to determine the best treatment approach for patients by assessing their risk through gene expression analysis. This means that the study will look at how genes are expressed in the cancer cells to decide on the most suitable treatment plan. The trial will involve different groups of patients who will receive either intensified or reduced treatment based on their risk level. The study will monitor the patients over time to see how well they respond to the treatment and to check for any side effects.
Throughout the study, researchers will track the time from diagnosis to any significant events, such as the cancer returning or worsening. They will also look at overall survival rates and other factors that might affect the outcomes, like the age at diagnosis and specific genetic changes in the cancer cells. The trial will compare the results with historical data to understand the effectiveness of the treatments and the impact of any side effects. This research is expected to continue until 2035, with patient recruitment starting in 2024.
Germany 