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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

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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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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    
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