Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma

NCT00077389 | Unknown Phase 2

• 4 other identifiers: CDR0000350221SIOP-SIOPEL-4EU-20336CCLG-LT-2004-09
• Study Type: interventional
• Target: 57
• Locations: 4 countries
• Sites: 24

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.

Conditions

Liver Cancer

Keywords

childhood hepatoblastoma; stage IV childhood liver cancer

Outcome Measures

Primary Outcomes (1)

• Rate of complete remission after completion of study therapy

Secondary Outcomes (5)

• 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

Interventions

carboplatin DRUG

cisplatin DRUG

doxorubicin hydrochloride DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (24)

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Emma Kinderziekenhuis

Amsterdam, NL-1100 DE, Netherlands

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Children's Cancer and Leukaemia Group

Leicester, England, LE1 6TH, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23831416 DERIVED

• 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.

  PMID: 23683550 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Hepatoblastoma

Interventions

Carboplatin; Cisplatin; Doxorubicin; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Margaret Childs

  Children's Cancer and Leukaemia Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: January 1, 2004
• Last Updated: June 24, 2014

Record last verified: 2009-12

Locations

FR (1); GB (21); NL (1); IE (1)