Study on Response and Biology-Based Risk Factor-Guided Therapy for Young Patients with Non-High Risk Neuroblastoma

Program Overview

This study is investigating a treatment strategy for young patients with non-high risk neuroblastoma, a cancer that affects nerve tissue. The approach involves monitoring the tumor closely and using specific biological markers to decide if and when treatment is needed. This method may help avoid unnecessary treatments and their side effects while ensuring effective care when required.

Description

The study has several main goals:

• To avoid immediate treatment for infants under 12 months with small neuroblastoma tumors, aiming for a survival rate of 99%.
• To avoid immediate treatment for children under 18 months with localized neuroblastoma and favorable biological features, also aiming for a 99% survival rate.
• To achieve a 3-year survival rate of over 81% for infants under 18 months with a specific type of neuroblastoma using a treatment plan based on how the tumor responds.

The study will also explore:

• How long it takes for tumors to progress and what interventions are needed.
• The behavior of chemotherapy drugs in the body.
• The genetic makeup of tumors at different stages.
• The appearance of tumor samples under a microscope.
• The success rate of treating tumors that return or progress.
• The rate of complications from procedures like biopsies and surgeries.
• Changes in tumor risk factors after observation or chemotherapy.

Participants are divided into three groups:

• Group A: Infants under 12 months with small tumors are observed for 96 weeks unless the disease progresses. Regular scans are conducted.
• Group B: Children under 18 months with localized tumors are observed for 3 years unless the disease progresses. If it does, they receive chemotherapy and are then observed again.
• Group C: Children at high risk receive immediate chemotherapy. Others are observed for 3 years unless the disease progresses, at which point they receive chemotherapy.

After treatment, patients are followed up annually for up to 10 years.

Eligibility Criteria

Locations