Intensified pre-operative chemotherapy and radical surgery for HIGH RISK HEPATOBLASTOMASIOPEL 4 - SIOPEL 4

• Conditions: Hepatoblastoma

• Registration Number: EUCTR2006-001271-38-IE
• Lead Sponsor: Our Lady's Hospital for Sick Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified