Standard risk hepatoblatoma in children MedDRA version: 17.1 Level: LLT Classification code 10019824 Term: Hepatoblastoma resectable System Organ Class: 100000004864
Conditions
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed newly diagnosed hepatoblastoma - Standard risk hepatoblastoma: - Age = 18 years and > 1 month - Written informed consent and national/local ethics committee and regulatory approval - Centre/country willing and able to organize audiometry at minimum required quality standard - Ability to comply with requirements for submission of material for central review (radiology, pathology and audiology) - For females of child-bearing potential, a negative pregnancy test prior to study treatment is required. - Any patient who is of reproductive age should agree to use adequate contraception for the duration of the trial. Are the trial subjects under 18? yes Number of subjects for this age range: 28 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - High risk hepatoblastoma: - Hepatocellular carcinoma - Treatment starting more than 15 days from written biopsy report. - Abnormal renal function defined as calculated GFR < 75% of the lower limit of normal for age, which over 2 years of age is < 60 ml/min/1.73 m2, at diagnosis - Any previous chemotherapy - Recurrent disease - Patient unable to follow the protocol for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Sodium Thiosulphate to reduce the hearing impairment caused by Cisplatin chemotherapy.; Secondary Objective: - To carefully monitor any potential impact of STS on response to Cisplatin and survival. - To assess the short- and long-term tolerability of the combination of STS and Cisplatin. - To prospectively evaluate and validate biological, radiological and pathological features of standard risk hepatoblastoma for future risk adapted management. - To investigate the effect of STS on the formation of Cisplatin-DNA adducts. - To prospectively collect patient DNA specifically for the analysis of possible genetic factors that may contribute to the development of treatment related ototoxicity and nephrotoxicity. ;Primary end point(s): - Rate of Brock grade greater than or equal to 1 hearing loss determined after end of trial treatment or at an age of at least 3.5 years, whichever is later.;Timepoint(s) of evaluation of this end point: The final analysis will be done once a definitive assessment of hearing impairment is available for 102 patients, or at the latest 3 years after the last patient has been enrolled. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Response to preoperative chemotherapy - Complete resection - Complete remission - Event free survival (EFS) - Overall survival (OS) - Toxicity as graded by CTCAE v3.0 - Long-term renal clearance - Feasibility of central audiology review ;Timepoint(s) of evaluation of this end point: OS and EFS endpoints will continue to be evaluated up to a follow-up of at least 5 years from the enrolment of the last patient. | — |
Countries
Belgium, Denmark, France, Ireland, Spain, United Kingdom
Contacts
Public ContactTrial Coordinator
University of Birmingham
Outcome results
None listed