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Status:

UNKNOWN

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

Lead Sponsor:

University of Leicester

Conditions:

Liver Cancer

Eligibility:

All Genders

Up to 17 years

Phase:

PHASE2

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...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy and short-term toxicity of intensified neoadjuvant chemotherapy in children with high-risk hepatoblastoma undergoing surgical resection. * Increase the r...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    57 Patients enrolled

    Trial Details

    Trial ID

    NCT00077389

    Start Date

    January 1 2004

    Last Update

    June 24 2014

    Active Locations (24)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (24 locations)

    1

    Institut Gustave Roussy

    Villejuif, France, F-94805

    2

    Our Lady's Hospital for Sick Children Crumlin

    Dublin, Ireland, 12

    3

    Emma Kinderziekenhuis

    Amsterdam, Netherlands, NL-1100 DE

    4

    Birmingham Children's Hospital

    Birmingham, England, United Kingdom, B4 6NH