Phase II study of combination chemotherapy and high-dose chemotherapy in treating young children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors

UMIN ID: UMIN000000546

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: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients recieve chemotherapy consisting of cyclophosphamide, etoposide, cisplatin and vincristine. Chemotherapy repeats every 4 weeks for 4 courses. Five weeks after the chemotherapy, patients recieve 2 courses of high-dose chemotherapy (HDC) with stem cell rescue. HDC-CCE consists of cyclophosphamide, etoposide, and cisplatin. HDC-TM consists of thiotepa and melphalan. Radiotherapy is not performed except progressive or refractory disease.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 3years-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