A multi-centre open label randomised phase III trial of the efficacy of Sodium Thiosulphate in reducing ototoxicity in patients receiving Cisplatin chemotherapy for standard risk hepatoblastoma - SIOPEL 6

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 115

Inclusion Criteria

- Histologically confirmed newly diagnosed hepatoblastoma
- Standard risk hepatoblastoma (defined in section 11.1)
- Age = 18 years and > 1 month
- Written informed consent and national/local ethics committee and regulatory approval
- Centre/country willing and able to organise audiometry at the minimum required quality
- standard and to provide the contact details of the Consultant Audiologist or Ear Nose and
- Throat Surgeon who will take the responsibility for seeing that this is done
- Ability to comply with requirements for submission of material for central review
- 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:
F.1.2 Adults (18-64 years) yes
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

- High risk hepatoblastoma
- Hepatocellular carcinoma
- Treatment starting more than 15 days from written biopsy report
- Abnormal renal function (defined in section 11.2)
- Any previous chemotherapy
- Recurrent disease
- Previous hypersensitivity to STS
- Patient unable to follow the protocol for any reason

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of Sodium Thiosulphate to reduce the hearing impairment caused by Cisplatin chemotherapy;Primary end point(s): - Rate of Brock grade =1 hearing loss determined after end of trial treatment or at an age of at least 3.5 years, whichever is later;<br> Secondary Objective: - To carefully monitor any potential impact of STS on response to Cisplatin and survival<br> - To assess the short- and long-term tolerability of the combination of STS and Cisplatin<br> - To prospectively evaluate and validate biological, radiological and pathological features of standard risk hepatoblastoma for future risk adapted management<br> - To investigate the effect of STS on the formation of Cisplatin-DNA adducts<br> - 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<br>

Secondary Outcome Measures

Name	Time	Method

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