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

• Conditions: Standard risk hepatoblatoma in children; MedDRA version: 17.0Level: LLTClassification code 10019824Term: Hepatoblastoma resectableSystem Organ Class: 100000004864

• Registration Number: EUCTR2007-002402-21-DK
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-05
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 115

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: 7
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
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 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

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.;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>;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.