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Phase II clinical trial of multidisciplinary therapy using risk classification based on residual tumor volume and WHO grading for pediatric ependymoma patients (JCCG EPN1501)

Phase II clinical trial of multidisciplinary therapy using risk classification based on residual tumor volume and WHO grading for pediatric ependymoma patients (JCCG EPN1501) - Phase II clinical trial of multidisciplinary therapy for pediatric ependymoma patients( JCCG EPN1501)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023803
Enrollment
40
Registered
2016-10-20
Start date
2016-10-20
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

Pediatric ependymoma

Interventions

Group A: The patients with gross total removal without residual tumor intraoperatively and without residual tumor on postoperative MRI(GTR1), or supratentrial tumor with WHO grade2_These patients shou

Sponsors

The Japan Children's Cancer Group(JCCG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Tumor removal or biopsy performed as an initial treatment, and diagnosed ependymoma by central review for pathological diagnosis according to the protocol 2) Within 6 weeks after tumor removal or biopsy 3) No dissemination other than initial tumor location 4) Age, no less than 3 years-old and under 20 years-old when they are included to this clinical trial 5) Without any previous radiation therap y and chemotherapy 6) ECOG Performance Status(PS) with no more than 3 7) Written informed consent on this clinical trial For no less than 16 years-old, Informed consent with patient and his or her alternatives For no more than 15 years-old, Informed consent with patient's alternatives

Exclusion criteria

Exclusion criteria: 1)Synchronous or an asynchronous(within 5 years) other cancer 2)Existing heart disease to be treated 3)Pregnant or during breast-feeding 4)Inappropriate inclusion judged by attending physician

Design outcomes

Primary

MeasureTime frame
2 Year - Progression Free Survival rate

Secondary

MeasureTime frame
2 Year - Progression Free Survival rate for each Group, WHO classification 2 Year - Overall Survival rate 5 Year - Progression Free Survival rate 5 Year - Overall Survival rate 7 Year - Progression Free Survival rate 7 Year - Overall Survival rate Re-operation rate after completion of chemotherapy Extent of surgical removal rate Response rate of chemotherapy Occurrence rate of adverse events (for al l cases, and for each Group) Relationship between molecular diagnosis and clinical characteristics Relationship between clinical characteristics and therapies and neuropsychological function

Countries

Japan

Contacts

Public ContactYamamoto Tetsuya

University of Tsukuba, Faculty of Medicine Neurosurgery

yamamoto_neurosurg@md.tsukuba.ac.jp029-853-3900

Outcome results

None listed

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