Phase II study of reduced-dose craniospinal irradiation and combination chemotherapy in treating pediatric patients with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors

UMIN ID: UMIN000000545

Registered date:08/12/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: medulloblastoma or supratentorial primitive neuroectodermal tumors
• Date of first enrollment: 2006/12/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients recieve chemotherapy consisting of cyclophosphamide, etoposide, cisplatin and vincristine. Radiotherapy was started concomitantly with the second course of chemotherapy. Radiation doses were 50 Gy to the primary site and 18 Gy to the craniospinal axis. <Standard-risk medulloblastoma> Chemotherapy repeats every 4 weeks for 5 courses. <High-risk medulloblastoma and sPNET> Chemotherapy repeats every 4 weeks for 4 courses. Five weeks after the chemotherapy, patients recieve high-dose chemotherapy consisting of thiotepa and melphalan with stem cell rescue.

Outcome(s)

• Primary Outcome: 3-year progression-free survival
• Secondary Outcome: 3-year overall survival

Key inclusion & exclusion criteria

• Age minimum: 3years-old
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: Has double cancer. Has cardiac disease for which treatment is necessary.

Related Information

• Primary Sponsor: Japanese Pediatric Brain Tumor Consortium
• Source(s) of Monetary Support: Osaka City