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Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077389
Recruitment Status : Unknown
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2004
Last Update Posted : June 24, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma
Study Start Date : January 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rate of complete remission after completion of study therapy

Secondary Outcome Measures :
  1. Complete resection rate
  2. Response rate to preoperative chemotherapy
  3. Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy
  4. Overall survival
  5. Event-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed hepatoblastoma
  • High-risk disease, meeting criteria for at least 1 of the following:

    • Tumor involving all 4 hepatic sections
    • Evidence of abdominal extrahepatic disease
    • Presence of metastases
    • Alpha-fetoprotein < 100 ng/mL at diagnosis
  • Must have had a prior diagnostic biopsy within the past 15 days
  • No recurrent disease



  • Under 18

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • AST and/or ALT ≤ 3 times normal


  • Glomerular filtration rate ≥ 60 mL/min


  • Shortening fraction ≥ 29% OR
  • Ejection fraction ≥ 40%


  • Not pregnant
  • Negative pregnancy test
  • No pre-existing clinically relevant bilateral hearing loss
  • No other condition that would preclude study participation


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No prior therapy for hepatoblastoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077389

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Institut Gustave Roussy
Villejuif, France, F-94805
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
Emma Kinderziekenhuis
Amsterdam, Netherlands, NL-1100 DE
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Children's Cancer and Leukaemia Group
Leicester, England, United Kingdom, LE1 6TH
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
University of Leicester
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Study Chair: Margaret Childs Children's Cancer and Leukaemia Group

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00077389     History of Changes
Other Study ID Numbers: CDR0000350221
First Posted: February 12, 2004    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: December 2009

Keywords provided by National Cancer Institute (NCI):
childhood hepatoblastoma
stage IV childhood liver cancer

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action