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

NCT07291102 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-12-18

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Bridging Chemotherapy

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

DRUG

Induction Cycles A1-A3

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

DRUG

Induction Cycles A4-5

Cisplatin, etoposide, cyclophosphamide, high-dose methotrexate

DRUG

Consolidation Cycle A6

Carboplatin, thiotepa, etoposide

DRUG

HIT-SKK Chemotherapy Cycles B1-3

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

DRUG

Modified HIT-SKK Cycle B4-5

Cyclophosphamide, vincristine, carboplatin, etoposide

Sponsors & Collaborators

  • German Society of Paediatric Oncology and Hematology (GPOH gGmbH)

    collaborator UNKNOWN

  • Children's of Alabama

    collaborator OTHER

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Maryam Fouladi, MD · Nationwide Children's Hospital

  • Girish Dhall, MD · Children's Hospital of Alabama

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2034-10-31
Completion
2038-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291102 on ClinicalTrials.gov