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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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Villejuif, Frankrijk, F-94805
- Institut Gustave Roussy
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Dublin, Ierland, 12
- Our Lady's Hospital for Sick Children Crumlin
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Amsterdam, Nederland, NL-1100 DE
- Emma Kinderziekenhuis
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England
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Birmingham, England, Verenigd Koninkrijk, B4 6NH
- Birmingham Children's Hospital
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Bristol, England, Verenigd Koninkrijk, BS2 8AE
- Institute of Child Health at University of Bristol
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Cambridge, England, Verenigd Koninkrijk, CB2 2QQ
- Addenbrooke's Hospital
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Leeds, England, Verenigd Koninkrijk, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, Verenigd Koninkrijk, LE1 5WW
- Leicester Royal Infirmary
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Leicester, England, Verenigd Koninkrijk, LE1 6TH
- Children's Cancer and Leukaemia Group
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Liverpool, England, Verenigd Koninkrijk, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, Verenigd Koninkrijk, W1T 3AA
- Middlesex Hospital
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London, England, Verenigd Koninkrijk, WC1N 3JH
- Great Ormond Street Hospital for Children
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Manchester, England, Verenigd Koninkrijk, M27 4HA
- Royal Manchester Children's Hospital
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Newcastle-Upon-Tyne, England, Verenigd Koninkrijk, NE1 4LP
- Sir James Spence Institute of Child Health at Royal Victoria Infirmary
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Nottingham, England, Verenigd Koninkrijk, NG7 2UH
- Queen's Medical Centre
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Oxford, England, Verenigd Koninkrijk, 0X3 9DU
- Oxford Radcliffe Hospital
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Sheffield, England, Verenigd Koninkrijk, S10 2TH
- Children's Hospital - Sheffield
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Southampton, England, Verenigd Koninkrijk, SO16 6YD
- Southampton General Hospital
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Sutton, England, Verenigd Koninkrijk, SM2 5PT
- Royal Marsden - Surrey
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Northern Ireland
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Belfast, Northern Ireland, Verenigd Koninkrijk, BT12 6BE
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, Verenigd Koninkrijk, AB25 2ZG
- Royal Aberdeen Children's Hospital
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Edinburgh, Scotland, Verenigd Koninkrijk, EH9 1LF
- Royal Hospital for Sick Children
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Glasgow, Scotland, Verenigd Koninkrijk, G3 8SJ
- Royal Hospital for Sick Children
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Wales
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Cardiff, Wales, Verenigd Koninkrijk, CF14 4XW
- Childrens Hospital for Wales
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Rate of complete remission after completion of study therapy
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Secundaire uitkomstmaten
Uitkomstmaat |
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Algemeen overleven
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Overleven zonder gebeurtenissen
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Volledig resectiepercentage
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Response rate to preoperative chemotherapy
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Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Margaret Childs, Children's Cancer and Leukaemia Group
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Neoplasmata van het spijsverteringsstelsel
- Lever Ziekten
- Neoplasmata, complex en gemengd
- Lever neoplasmata
- Hepatoblastoom
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antibiotica, antineoplastiek
- Carboplatine
- Doxorubicine
- Liposomale doxorubicine
Andere studie-ID-nummers
- CDR0000350221
- SIOP-SIOPEL-4
- EU-20336
- CCLG-LT-2004-09
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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