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Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma

ConditionMedulloblastoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 5
SponsorNationwide Children's Hospital

About this trial

This is a trial to compare neurocognitive outcomes in the intent-to-treat population 2.5 years after diagnosis between patients with newly diagnosed, non-metastatic, SHH-activated, TP53-wt, non-MYC amplified MF randomized to the interventional arms A ("Head Start 4") or B (HIT-SKK).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at diagnosis < 5 years

Patients with institutional suspicion or diagnosis of SHH-activated MB

Patient and family in social circumstances that will allow neuropsychological follow-up

Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures

Disqualifiers

Patients previously treated for any other brain tumor or any type of malignant disease

Patients, in whom compliance with toxicity management guidelines and study procedures cannot be assured

History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of an investigational medicinal product.

Patients/parents who do not wish to abstain from treatment with live vaccines during study participation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bridging Chemotherapy

    Drug

    One bridging chemotherapy cycle consists of five days of therapy using Carboplatin and etoposide

  • Induction Cycles A1-A3

    Drug

    Cisplatin, vincristin, etoposide, cyclophosphamide, high-dose methotrexate

  • Induction Cycles A4-5

    Drug

    Cisplatin, etoposide, cyclophosphamide, high-dose methotrexate

  • Consolidation Cycle A6

    Drug

    Carboplatin, thiotepa, etoposide

  • HIT-SKK Chemotherapy Cycles B1-3

    Drug

    Cyclophosphamide, vincristine, high-dose methotrexate, carboplatin, etoposide, i.ventri. methotrexate

  • Modified HIT-SKK Cycle B4-5

    Drug

    Cyclophosphamide, vincristine, carboplatin, etoposide

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Arm A: "Head Start" 4Experimental treatment 4 interventions
Group B: Arm B: HIT-SKKExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Neurocognitive Outcomes using WPPSIIV

To compare neurocognitive outcomes 2.5 years after diagnosis between patients randomized to the interventional arms A ("Head Start" 4) and B (HIT-SKK). Full-Scale Intelligence Quotient (IQ) as measured by the Wechsler Preschool and Primary Scale of Intelligence (WPPSIIV) administered to those between the ages of 2 years and 6 months to 7 years and 7 months old at 2.5 years after diagnosis (+/- 6 months).

Time frame
105 months

Secondary outcomes

1

PFS

Progression-free survival (PFS) compared between randomized groups

Time frame
152 months
2

rtPFS

Radiotherapy-free/progression-free survival (rtPFS) compared between randomized groups

Time frame
152 months
3

OS

Overall survival (OS) compared between randomized groups

Time frame
152 months
4

Second malignancies

Incidence of second malignancies compared between randomized groups

Time frame
152 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nationwide Children's Hospital

Lead sponsor

German Society of Paediatric Oncology and Hematology (GPOH gGmbH)

Collaborator

Children's of Alabama

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: