EUCTR2006-001271-38-IE
Active, not recruiting
Not Applicable
Intensified pre-operative chemotherapy and radical surgery for HIGH RISK HEPATOBLASTOMASIOPEL 4 - SIOPEL 4
Our Lady's Hospital for Sick Children0 sites57 target enrollmentMay 15, 2006
ConditionsHepatoblastoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatoblastoma
- Sponsor
- Our Lady's Hospital for Sick Children
- Enrollment
- 57
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?Histologically confirmed hepatoblastoma
- •?Risk category: high\-risk (as defined above)
- •?Written informed consent and national/local ethical committee approval
- •?Ability to comply with requirements for submission of materials for central review
- •?Age less than 18 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •All patients who do not fulfil the eligibility criteria of the protocol are excluded from the trial Additional exclusion criteria are:
- •?Diagnosis not confirmed by histology
- •?Age greater thsn or equal to 18 years
- •?Any previous chemotherapy or any previous treatment for hepatoblastoma
- •?Interval between date of diagnostic biopsy and start of chemotherapy \> 15 days
- •?Abnormal renal function at diagnosis defined as GFR \< 75\-50% of the lower limit of normal for age which over 2 years of age is \< 60 ml/min/1\.73 mP2 P
- •?Patient unable to follow the protocol for any reason.
- •?Patients referred for recurrent disease
- •?No written informed consent or no ethical committee approval
Outcomes
Primary Outcomes
Not specified
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