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

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

Show Detailed Description

Study Design


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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Hepatoblastoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Rate of complete remission after completion of study therapy

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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


France
Institut Gustave Roussy
Villejuif, France, F-94805
Ireland
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
Netherlands
Emma Kinderziekenhuis
Amsterdam, Netherlands, NL-1100 DE
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Children's Cancer and Leukaemia Group
Leicester, England, United Kingdom, LE1 6TH
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW

Sponsors and Collaborators

University of Leicester

Investigators


Study Chair:	Margaret Childs	Children's Cancer and Leukaemia Group

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Brugières L, Roebuck D, Fabre M, Zimmermann A, Otte JB, Sullivan M, Perilongo G, Childs M, Brock P, Zsíros 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.


ClinicalTrials.gov Identifier:	NCT00077389 History of Changes
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:


Liver Neoplasms Hepatoblastoma Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type	Liposomal doxorubicin Carboplatin Doxorubicin Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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