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TPS10094 : SIOPEL 6: A multicenter open-label randomized phase III trial of the efficacy of sodium thiosulphate (STS) in reducing ototoxicity in patients receiving cisplatin (Cis) monotherapy for standard-risk hepatoblastoma (SR-HB).

Researchers

Presenter

  • Rudolf Maibach

Principal Investigators

  • Kaukab Rajput

  • Benedicte Brichard

  • Jane Skeen

  • Maria Elena Mateos Gonzales

  • Monique Fabre

  • Giorgio Perilongo

  • Piotr Czauderna

  • Bruce Morland

  • Michael James Sullivan

  • Veronique Laithier

  • Milind Ronghe

  • Liane Lockwood

  • Patrizia dall'Igna

  • Eiso Hiyama

  • Penelope Brock

  • Edward A. Neuwelt

  • Derek Roebuck

Medical Centers

  • Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom

  • University Hospital Reina Sofia, Cordoba, Spain

  • Institut de Cancerologie Gustave Roussy, Villejuif, France

  • University of Pavia, Pavia, Italy

  • Paediatric Haematology Oncology Division, University of Padova, Padova, Italy

  • Great Ormond Street Hospital, London, United Kingdom

  • Medical University of Gdansk, Gdansk, Poland

  • IBCSG Coordinating Center, Bern, Switzerland

  • Cliniques Universitaires Saint-Luc, UCL, Brussels, MN, Belgium

  • Centre Hospitalier Universitaire Besancon, Besancon, FranceRoyal Hospital for Sick Children, Glasgow, United KingdomNottingham Clinical Trials Unit, Nottingham NG7 2UH, United Kingdom

  • Oregon Health and Science University, Portland, OR

  • Hiroshima Univerisity, Natural Science Center for Basic Research and Development, Hiroshima, Japan

  • Birmingham Children's Hospital, Birmingham, United Kingdom

  • Starship Children's Hospital, Auckland, New Zealand

  • Childrens Cancer Research Group, Christchurch School of Medicine, Christchurch, New Zealand

  • Lady Cilento Childrens Hospital, Brisbane, Australia

Locations

  • Japan

  • Italy

  • Poland

  • Spain

  • United Kingdom

  • Switzerland

  • Australia

  • United States

  • France

  • Belgium

  • New Zealand

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Hepatoblastoma

Biomarkers

  • Alpha-fetoprotein

Drug/Treatment

  • sodium thiosulfate

  • Doxorubicin

  • Cisplatin

Outcome

  • Unknown

Study Design

  • randomized

Phase

  • III

Study Id's

  • NCT00652132

Sponsors

  • N/A

Result

  • Interim

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