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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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 Design
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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

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Arms and Interventions
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Outcome Measures
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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

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Under 18

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • AST and/or ALT ≤ 3 times normal

Renal

  • Glomerular filtration rate ≥ 60 mL/min

Cardiovascular

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

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior therapy for hepatoblastoma
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00077389


Locations
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Sponsors and Collaborators
University of Leicester
Investigators
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Study Chair: Margaret Childs Children's Cancer and Leukaemia Group
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00077389    
Other Study ID Numbers: CDR0000350221
SIOP-SIOPEL-4
EU-20336
CCLG-LT-2004-09
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
Hepatoblastoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Cisplatin
 Carboplatin
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action