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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma

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.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the efficacy and short-term toxicity of intensified neoadjuvant chemotherapy in children with high-risk hepatoblastoma undergoing surgical resection.
  • Increase the rate of complete surgical resection in these patients by fully implementing liver transplantation as a valid treatment option for tumor removal when partial liver resection or other surgical options remain unfeasible even after extensive preoperative chemotherapy.
  • Determine, prospectively, the role of this regimen in rendering unresectable tumors resectable in these patients.
  • Determine the accuracy of initial imaging in predicting the surgical options (after treatment with this regimen) for patients presenting with unresectable disease.

Secondary

  • Determine the overall survival and event-free survival of patients treated with this regimen (with an acceptable overall toxicity).
  • Determine the toxicity of this regimen in these patients.
  • Determine the response rate in patients treated with this regimen.
  • Determine whether response to this regimen, defined by the modified RECIST criteria, can be used for better monitoring of response in these patients.
  • Determine whether a fall in alpha-fetoprotein during this neoadjuvant regimen can be used as a prognostic factor in these patients.
  • Determine, prospectively, radiological, surgical, and pathological characteristics of the tumor that might identify po
    Sponsor: University of Leicester

    Current Primary Outcome: Rate of complete remission after completion of study therapy

    Original Primary Outcome:

    Current Secondary Outcome:

    • 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


    Original Secondary Outcome:

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: February 10, 2004
    Date Started: January 2004
    Date Completion:
    Last Updated: June 23, 2014
    Last Verified: December 2009