JCCG EPN23: A phase2 study to evaluate the efficacy and safety of the multimodality therapy using treatment stratification in pediatric ependymoma

JRCT ID: jRCTs041240110

Registered date:23/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: intracranial ependymoma
• Date of first enrollment: 01/12/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Surgical resection, chemotherapy, radiotherapy

Outcome(s)

Primary Outcome

Stratum 1: Non unresectable recurrence rate
Stratum 2: Event-free survival (EFS) in 2 years
Stratum 3: Total removal/Complete response Rate

Secondary Outcome

Assessment of Efficacy
Assessment of Safety

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 30age old
• Gender: Both

Include criteria

1) Tumor removal or biopsy for the primary lesion is performed at the time of first occurrence, and the pathological diagnosis of ependymoma is obtained in each institution, and specimens are scheduled to be sent to the central pathology.
2) Registered in the observational study for pediatric solid tumors by Japan Children's Oncology Group (JCCG).
3) Within 6 weeks of tumor removal or biopsy.
4) No evidence of dissemination by head and spinal MRI
5) 1 years or older, less than 30 years.
6) No prior chemotherapy or head radiation therapy for any intracranial tumors.
7) ECOG performance status (PS) of 0, 1, 2, or 3
8) Written informed consent is obtained from the patient or his/her legal guardian.

Exclude criteria

1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less).
2) Complicated heart disease requiring treatment.
3) Pregnant or nursing.
4) Cases in which the radiologist considers that it is difficult to perform radiotherapy as specified in the protocol.
5) Judgement of inappropriate inclusion by physician

Related Information

• Primary Sponsor: Saito Ryuta
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development