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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 because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077389
First received: February 10, 2004
Last updated: June 23, 2014
Last verified: December 2009

February 10, 2004
June 23, 2014
January 2004
Not Provided
Rate of complete remission after completion of study therapy [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00077389 on ClinicalTrials.gov Archive Site
  • Complete resection rate [ Designated as safety issue: No ]
  • Response rate to preoperative chemotherapy [ Designated as safety issue: No ]
  • Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
Not Provided
Not Provided
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Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma

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.

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 possible novel factors that might influence treatment choice and outcome in these patients.

OUTLINE: This is an open-label, multicenter study.

  • Intensified neoadjuvant chemotherapy: Patients receive cisplatin IV over 24 hours on days 1, 8, 15, 29, 36, 43, 57, and 64; and doxorubicin IV over 1 hour OR over 24 hours on days 8, 9, 36, 37, 57, and 58. Patients determined to have resectable disease proceed to surgery.

Patients determined to have unresectable disease after neoadjuvant chemotherapy receive additional neoadjuvant chemotherapy comprising carboplatin IV over 1 hour on days 1 and 22 and doxorubicin IV over 1 hour OR over 24 hours on days 1, 2, 3, 22, 23, and 24.

Treatment continues in the absence of unacceptable toxicity.

  • Surgery: Patients determined to have resectable disease undergo complete resection and possibly liver transplantation.
  • Adjuvant chemotherapy*: Patients who undergo complete surgical resection receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1 hour OR over 24 hours on days 1 and 2. Treatment repeats every 3 weeks for a total of 3 courses.

NOTE: *Patients who received additional neoadjuvant chemotherapy for unresectable disease do not receive adjuvant chemotherapy.

Patients are followed every 2-3 months for 2 years, every 3 months for 1 year, and then every 6 months for 2 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 23-57 patients will be accrued for this study within 2 years.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: doxorubicin hydrochloride
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
Not Provided
Not Provided

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Ireland,   Netherlands,   United Kingdom
 
NCT00077389
CDR0000350221, SIOP-SIOPEL-4, EU-20336, CCLG-LT-2004-09
Not Provided
Not Provided
University of Leicester
Not Provided
Study Chair: Margaret Childs Children's Cancer and Leukaemia Group
National Cancer Institute (NCI)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP