Hepatoblastoma
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Trade Name: Doxorubicin
Product Name: Doxorubicin
Phar
Sponsors
Our Lady's Hospital for Sick Children
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To determine the effectiveness and short-term toxicity of an intensified new chemotherapy regime in children with high risk hepatoblastoma. ?To increase the rate of complete surgical resection by full implementation of liver transplantation in the treatment strategy as a valid option for tumour removal when partial liver resection or other surgical options remain unfeasible even after extensive pre-operative chemotherapy. ?To evaluate prospectively the role of pre-operative chemotherapy in rendering unresectable tumours, resectable. ?To assess the accuracy of initial imaging in predicting the surgical options after pre-operative chemotherapy in children presenting with unresectable disease. ;Secondary Objective: ?Improve overall and EFS with acceptable toxicity ?Assess toxicity of Cisplatin intensive regimen ?Assess response rate to pre-operative chemotherapy ?Assess whether response to chemotherapy defined by the modified RECIST criteria can be used for better response monitoring ?Assess whether the fall of AFP during pre-operative chemotherapy can be used as a prognostic factor ?Further evaluate feasibility of rapid central review of pre-treatment tumour extent of disease and resectability for 'difficult' patients ?Prospectively collect radiological, surgical and tumour pathological characteristics data to identify novel factors that may influence treatment choice and disease outcome ?Continue collecting biological materials derived from HB patients to improve knowledge of the pathology and biology of HB and facilitate research on this tumour ?Improve clinical care by giving guidelines for the diagnostic, therapeutic and follow-up management of these patients ;Primary end point(s): Primary end-point: ?The primary endpoint of the trial is the rate of complete remission (CR) after the end of trial treatment (chemotherapy and partial resection or liver transplant), defined as a normal serum AFP level and absence of disease on imaging (abdominal ul | — |
Countries
Ireland
Outcome results
None listed