SIOPEL 6

Phase 1

• Conditions: Standard risk hepatoblatoma in children; MedDRA version: 18.0 Level: LLT Classification code 10019824 Term: Hepatoblastoma resectable System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-002402-21-IE
• Lead Sponsor: Our lady's Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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: 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

- 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