Study: NCT05535166

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgical resection
Description: All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a second-look surgery may be performed between cycles of chemotherapy after discussion with the principal investigator.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgical resection
Description: All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a second-look surgery may be performed between cycles of chemotherapy after discussion with the principal investigator.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgical resection
Description: All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a second-look surgery may be performed between cycles of chemotherapy after discussion with the principal investigator.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ommaya/VPS
Description: All participants enrolled on S-1 will undergo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Route of administration: Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegfilgrastim
Description: Route of administration: subcutaneous (SQ)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegfilgrastim
Description: Route of administration: subcutaneous (SQ)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegfilgrastim
Description: Route of administration: subcutaneous (SQ)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Filgrastim
Description: Route of administration: subcutaneous (SQ) or Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Filgrastim
Description: Route of administration: subcutaneous (SQ) or Intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Filgrastim
Description: Route of administration: subcutaneous (SQ) or Intravenously (IV)

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Irradiation
Description: All participants in stratum N will undergo craniospinal irradiation (CSI) with boost to the primary tumor site once they reach 36 months of age. The dose given is based on the molecular risk group and disease response to chemotherapy as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Educational and Media Intervention
Description: Participants watch a 75-minute caregiver education video program and receive access to interactive games on a smartphone or tablet throughout the optional cognitive study.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: SOC, Educational and Media Intervention
Description: Standard-of-care (SOC) treatment during main cognitive study. After the one-year serial cognitive evaluation, participants will be offered participation in the cognitive study group I intervention.