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Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer
Not Recruiting
Trial ID: NCT00652132
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. It is not yet known whether giving sodium thiosulfate is effective in reducing hearing damage caused by cisplatin in treating young patients with liver cancer.
PURPOSE: This randomized phase III trial is studying how well sodium thiosulfate works to decrease hearing loss caused by cisplatin in treating young patients with stage I, stage II, or stage III childhood liver cancer.
Official Title
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
Eligibility
Inclusion Histologically confirmed newly diagnosed hepatoblastoma
* Standard risk hepatoblastoma (Pretext I,II,III)
* 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.
Exclusion:
High risk hepatoblastoma
* Hepatocellular carcinoma
* Treatment starting more than 15 days from written biopsy report
* Abnormal renal function
* Any previous chemotherapy
* Recurrent disease
* Previous hypersensitivity to STS
* Patient unable to follow the protocol for any reason
Intervention(s):
drug: cisplatin
drug: sodium thiosulfate
genetic: gene rearrangement analysis
genetic: microarray analysis
genetic: proteomic profiling
other: immunohistochemistry staining method
other: laboratory biomarker analysis
procedure: adjuvant therapy
procedure: neoadjuvant therapy
procedure: therapeutic conventional surgery
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305