Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
NCT ID: NCT00077389
Last Updated: 2014-06-24
Study Results
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Basic Information
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UNKNOWN
PHASE2
57 participants
INTERVENTIONAL
2004-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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carboplatin
cisplatin
doxorubicin hydrochloride
adjuvant therapy
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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University of Leicester
OTHER
Principal Investigators
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Margaret Childs
Role: STUDY_CHAIR
Children's Cancer and Leukaemia Group
Locations
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Institut Gustave Roussy
Villejuif, , France
Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Emma Kinderziekenhuis
Amsterdam, , Netherlands
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Children's Cancer and Leukaemia Group
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Middlesex Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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References
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Zsiros J, Brugieres L, Brock P, Roebuck D, Maibach R, Zimmermann A, Childs M, Pariente D, Laithier V, Otte JB, Branchereau S, Aronson D, Rangaswami A, Ronghe M, Casanova M, Sullivan M, Morland B, Czauderna P, Perilongo G; International Childhood Liver Tumours Strategy Group (SIOPEL). Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study. Lancet Oncol. 2013 Aug;14(9):834-42. doi: 10.1016/S1470-2045(13)70272-9. Epub 2013 Jul 4.
Weeda VB, Murawski M, McCabe AJ, Maibach R, Brugieres L, Roebuck D, Fabre M, Zimmermann A, Otte JB, Sullivan M, Perilongo G, Childs M, Brock P, Zsiros J, Plaschkes J, Czauderna P, Aronson DC. Fibrolamellar variant of hepatocellular carcinoma does not have a better survival than conventional hepatocellular carcinoma--results and treatment recommendations from the Childhood Liver Tumour Strategy Group (SIOPEL) experience. Eur J Cancer. 2013 Aug;49(12):2698-704. doi: 10.1016/j.ejca.2013.04.012. Epub 2013 May 15.
Other Identifiers
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SIOP-SIOPEL-4
Identifier Type: -
Identifier Source: secondary_id
EU-20336
Identifier Type: -
Identifier Source: secondary_id
CCLG-LT-2004-09
Identifier Type: -
Identifier Source: secondary_id
CDR0000350221
Identifier Type: -
Identifier Source: org_study_id
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