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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 10, 2004
Last updated: June 23, 2014
Last verified: December 2009

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 Intervention Phase
Liver Cancer
Drug: carboplatin
Drug: cisplatin
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

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

Estimated Enrollment: 57
Study Start Date: January 2004
  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00077389

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
Study Chair: Margaret Childs Children's Cancer and Leukaemia Group
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00077389     History of Changes
Other Study ID Numbers: CDR0000350221
Study First Received: February 10, 2004
Last Updated: June 23, 2014

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

Additional relevant MeSH terms:
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 processed this record on April 28, 2017