- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00077389
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Villejuif, Frankreich, F-94805
- Institut Gustave Roussy
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Dublin, Irland, 12
- Our Lady's Hospital for Sick Children Crumlin
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Amsterdam, Niederlande, NL-1100 DE
- Emma Kinderziekenhuis
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England
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Birmingham, England, Vereinigtes Königreich, B4 6NH
- Birmingham Children's Hospital
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Bristol, England, Vereinigtes Königreich, BS2 8AE
- Institute of Child Health at University of Bristol
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Cambridge, England, Vereinigtes Königreich, CB2 2QQ
- Addenbrooke's Hospital
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Leeds, England, Vereinigtes Königreich, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, Vereinigtes Königreich, LE1 5WW
- Leicester Royal Infirmary
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Leicester, England, Vereinigtes Königreich, LE1 6TH
- Children's Cancer and Leukaemia Group
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Liverpool, England, Vereinigtes Königreich, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, Vereinigtes Königreich, W1T 3AA
- Middlesex Hospital
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London, England, Vereinigtes Königreich, WC1N 3JH
- Great Ormond Street Hospital for Children
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Manchester, England, Vereinigtes Königreich, M27 4HA
- Royal Manchester Children's Hospital
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Newcastle-Upon-Tyne, England, Vereinigtes Königreich, NE1 4LP
- Sir James Spence Institute of Child Health at Royal Victoria Infirmary
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Nottingham, England, Vereinigtes Königreich, NG7 2UH
- Queen's Medical Centre
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Oxford, England, Vereinigtes Königreich, 0X3 9DU
- Oxford Radcliffe Hospital
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Sheffield, England, Vereinigtes Königreich, S10 2TH
- Children's Hospital - Sheffield
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Southampton, England, Vereinigtes Königreich, SO16 6YD
- Southampton General Hospital
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Sutton, England, Vereinigtes Königreich, SM2 5PT
- Royal Marsden - Surrey
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Northern Ireland
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Belfast, Northern Ireland, Vereinigtes Königreich, BT12 6BE
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, Vereinigtes Königreich, AB25 2ZG
- Royal Aberdeen Children's Hospital
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Edinburgh, Scotland, Vereinigtes Königreich, EH9 1LF
- Royal Hospital for Sick Children
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Glasgow, Scotland, Vereinigtes Königreich, G3 8SJ
- Royal Hospital for Sick Children
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Wales
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Cardiff, Wales, Vereinigtes Königreich, CF14 4XW
- Childrens Hospital for Wales
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Rate of complete remission after completion of study therapy
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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Gesamtüberleben
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Ereignisfreies Überleben
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Vollständige Resektionsrate
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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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Margaret Childs, Children's Cancer and Leukaemia Group
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Neoplasmen des Verdauungssystems
- Leberkrankheiten
- Neubildungen, komplex und gemischt
- Lebertumoren
- Hepatoblastom
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Antibiotika, antineoplastische
- Carboplatin
- Doxorubicin
- Liposomales Doxorubicin
Andere Studien-ID-Nummern
- CDR0000350221
- SIOP-SIOPEL-4
- EU-20336
- CCLG-LT-2004-09
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