Phase II study of new risk classification and high-dose chemotherapy for medulloblastoma

Phase II study to evaluate the efficacy and safety of the introduction of high-dose chemotherapy comprising thiotepa and melphalan to conventional chemoradiotherapy depending on new risk classification for medulloblastoma - JCCG MB19

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200021

Enrollment

229

Registered

2020-05-28

Start date

2020-06-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medulloblastoma Medulloblastoma

Interventions

With the introduction of new risk classification that combines the molecular classification and the conventional risk factor (M stage), three risk groups for ages 4 and older (low risk (LR), standard

D017427

high dose chemotherapy, thiotepa, double conditioning, molecular classification

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Locally diagnosed as medulloblastoma after tumor resection or biopsy 2) Protocol treatment can be started within 6 weeks after surgery 3) Less than 30 years 4) No prior radiation or chemotherapy 5) ECOG Performance Status (PS) is 3 or less

Exclusion criteria

Exclusion criteria: 1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less). 2) Complicated with extracranial metastasis (M4). 3) Complicated heart disease requiring treatment. 4) You are pregnant or nursing.

Design outcomes

Primary

Measure	Time frame
Age greater than or equal to 4 years without metastases: 5yr progression-free survival Age greater than or equal to 4 years with metastases: 5yr progression-free survival Age less than 4 years without metastases: 3yr progression-free survival Age less than 4 years with metastases: 3yr progression-free survival	—

Secondary

Measure	Time frame
3yr and 5 yr overall survival Response rate Pattern of relapse Rate of adverse effect (CTCAE grade 3-5) Neurocognitive function (2yr and 5yr) Rate of secondary neoplasms (2yr and 5yr) Rate of endocrine disorders (2yr and 5yr) Rate of cerebrovascular event (2yr and 5yr) Confirmation rate of risk classification based on molecular classification	—

Contacts

Public ContactKai Yamasaki

Department of Pediatric Hematology and Oncology, Osaka City General Hospital

ka-yamasaki@med.osakacity-hp.or.jp+81-6-6929-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026