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Sponsored by: |
Children's Cancer and Leukaemia Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00652132 |
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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Liver Cancer |
Drug: cisplatin Drug: sodium thiosulfate Procedure: adjuvant therapy Procedure: gene expression profiling Procedure: gene rearrangement analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: proteomic profiling Procedure: therapeutic conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
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 |
Estimated Enrollment: | 115 |
Study Start Date: | December 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to country, median age (< 15 months vs ≥ 15 months), and PRETEXT tumor classification (I vs II vs III). Patients are randomized to 1 of 2 treatment arms.
Patients undergo blood collection and tumor biopsies periodically for biological and pharmacological studies consisting of biomarker analysis, gene expression profiling, IHC, proteomic analysis, and gene rearrangement analysis. Patients undergo auditory evaluations at baseline, and at the completion of study treatment or at an age of at least 3.5 years to measure ototoxicity and hearing impairment.
After completion of study treatment, patients are followed periodically for at least 5 years.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed standard-risk hepatoblastoma, meeting all of the following criteria:
Newly diagnosed disease
No high-risk hepatoblastoma meeting any of the following criteria:
Any of the following additional PRETEXT criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Contact Person 44-1223-348-151 amos.burke@addenbrookes.nhs.uk | |
Great Ormond Street Hospital for Children | Recruiting |
London, England, United Kingdom, WC1N 3JH | |
Contact: Contact Person 44-20-7829-7924 brockp@gosh.nhs.uk | |
Royal Manchester Children's Hospital | Recruiting |
Manchester, England, United Kingdom, M27 4HA | |
Contact: Contact Person 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
Sheffield Hallam University - City Campus | Recruiting |
Sheffield, England, United Kingdom, S1 1WB | |
Contact: Contact Person 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
United Kingdom, Scotland | |
Royal Aberdeen Children's Hospital | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
Contact: Contact Person 44-1224-550-217 veronica.neefjes@nhs.net | |
Royal Hospital for Sick Children | Recruiting |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Contact: Contact Person 44-141-201-9309 milind.ronghe@yorkhill.scot.nhs.uk |
Principal Investigator: | Milind D. Ronghe, MD | Royal Hospital for Sick Children |
Study ID Numbers: | CDR0000590649, CCLG-LT-2007-03, EU-20833, EUDRACT-2007-002402-21, SIOP-CCLG-LT-2007-03 |
Study First Received: | April 2, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00652132 |
Health Authority: | Unspecified |
ototoxicity childhood hepatoblastoma stage I childhood liver cancer stage II childhood liver cancer stage III childhood liver cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin |
Sodium thiosulfate Liver neoplasms Gastrointestinal Neoplasms Hepatoblastoma |
Anti-Infective Agents Neoplasms by Histologic Type Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Protective Agents Pharmacologic Actions Anti-Bacterial Agents |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Chelating Agents Antitubercular Agents Neoplasms, Complex and Mixed Antidotes |