Dettagli per singolo studio

DEC-NET Serial number ES381

Published online	04/04/2005 12.03.00
Last updated	26/06/2006 9.32.20

Other protocol ID number	PNET 4
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Malignant neoplasm of brain
Gender	Both
Age (range)	3-21 years old
Eligibility criteria
Inclusion criteria
Diagnosis of medulloblastoma; no CNS metastasis; no evidence of metastasis outside the CNS; no tumor cells in lumbar cerebrospinal fluid (lumbar punction performed at least 15 days after surgery); residual tumor after surgery with a diameter < or = 1,5 cm2; children able to start radiotherapy within the 40 days after the surgery, and to receive it twice a day. Hematological, renal, endocrinological and audiological function as defined in the protocol.
Exclusion criteria
Metastatic medulloblastoma; primitive neuroectodermal tumor of the trunk or supratentorial; patients previously treated because of a brain neoplasm or any other malignant neoplasm; pregnancy; others.
Trial design/methodology
Phase	4
Kind of study	Efficacy Safety
Design	Controlled Randomised
Purpose of study
Compare the event-free survival rate in pediatric patients with standar risk medulloblastoma treated with conventional vs hyperfractionated radiotherapy.
Primary outcomes
Survival (free of progression, or local or distal reincidence of tumor, or death for any cause) after 3 years
Secondary outcomes
Global survival Relapse pattern Long term consequences in health Quality of life Hypoacusia Hormonal lack Tumoral markers Toxicity of the neurosurgery
Summary of study design, objectives, and ongoing research findings
An amendmend was added in order to exclude patients with large cell anaplastic medulloblastoma.