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International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma

StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Primary and study completion dates: Apr 2024 to Dec 2026v7 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: Maintenance chemotherapy (Drug), Radiotherapy with Carboplatin (Radiation), Radiotherapy without Carboplatin (Radiation), Reduced-intensity… to Induction Chemotherapy (Drug), Maintenance chemotherapy (Drug), Radiotherapy with Carboplatin (Radiation), Radiotherapy without Carboplatin…
    • Study description expanded, about 101 words
    • Study sites revised (77)
    • Study arms: 2 to 4
  3. Study sites revised (77)v6
  4. Site details revised at 4 of 77 sitesv5
  5. Study sites: 76 to 77v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 73 to 76
    • Eligibility criteria expanded, about 132 words
    • Study description revised
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2014 to Jun 2014
    • Site details revised at 73 of 73 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms. With the amendment for version 12 of the protocol, patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study, and patients with a high-risk SHH medulloblastoma with TP53 mutation (both somatic or germline including mosaicism) can be included in the PNET5 MB SHH-TP53 study. Data on patients with pathogenic germline alteration or cancer predisposition syndrome, who cannot be included in any prospective trial due to unavailability or due to physician or family decision, can be documented within the observational PNET 5 MB registry.
Trial Details
NCT Number NCT02066220
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators: Deutsche Kinderkrebsstiftung
Conditions
(from sponsor)		 Brain Tumors
Related terms Brain Neoplasms, Medulloblastoma, Neuroectodermal Tumors, Primitive
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov