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Sponsored by: |
University Hospitals, Leicester |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077389 |
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 | Intervention | Phase |
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Liver Cancer |
Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma |
Estimated Enrollment: | 57 |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Treatment continues in the absence of unacceptable toxicity.
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.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
High-risk disease, meeting criteria for at least 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Laurence Brugieres, MD 33-1-4211-4180 | |
Ireland | |
Our Lady's Hospital for Sick Children Crumlin | Recruiting |
Dublin, Ireland, 12 | |
Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie | |
Netherlands | |
Emma Kinderziekenhuis | Recruiting |
Amsterdam, Netherlands, NL-1100 DE | |
Contact: Jozsef Zsiros, MD, PhD 31-20-566-9111 j.zsiros@amc.uva.nl | |
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Amos Burke, MD 44-1223-348-151 | |
Birmingham Children's Hospital | Recruiting |
Birmingham, England, United Kingdom, B4 6NH | |
Contact: Martin W. English, MD 44-121-333-8412 martin.english@bch.nhs.uk | |
Children's Cancer and Leukaemia Group | Recruiting |
Leicester, England, United Kingdom, LE1 6TH | |
Contact: Margaret Childs 44-0115-252-2380 | |
Middlesex Hospital | Recruiting |
London, England, United Kingdom, W1T 3AA | |
Contact: Ananth Shankar, MD 44-20-7380-9300 ext. 9950 | |
Great Ormond Street Hospital for Children | Recruiting |
London, England, United Kingdom, WC1N 3JH | |
Contact: Penelope Brock, MD, PhD 44-20-7829-7924 Brockp@gosh.nhs.uk | |
Institute of Child Health at University of Bristol | Recruiting |
Bristol, England, United Kingdom, BS2 8AE | |
Contact: Pamela Kearns, MD 44-117-342-0205 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |
Leicester Royal Infirmary | Recruiting |
Leicester, England, United Kingdom, LE1 5WW | |
Contact: Mabrouk Madi, MD 44-116-258-5959 | |
Children's Hospital - Sheffield | Recruiting |
Sheffield, England, United Kingdom, S10 2TH | |
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
Oxford Radcliffe Hospital | Recruiting |
Oxford, England, United Kingdom, 0X3 9DU | |
Contact: Kate Wheeler, MD 44-186-522-1066 | |
Queen's Medical Centre | Recruiting |
Nottingham, England, United Kingdom, NG7 2UH | |
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 63394 martin.hewitt@nuh.nhs.uk | |
Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
Liverpool, England, United Kingdom, L12 2AP | |
Contact: Heather P. McDowell, MD 44-151-293-3679 | |
Royal Manchester Children's Hospital | Recruiting |
Manchester, England, United Kingdom, M27 4HA | |
Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Mary Taj, MD 44-20-8642-6011 ext. 3089 | |
Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
United Kingdom, Northern Ireland | |
Royal Belfast Hospital for Sick Children | Recruiting |
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |
United Kingdom, Scotland | |
Royal Aberdeen Children's Hospital | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
Contact: Veronica Neefjes 44-1224-550-217 | |
Royal Hospital for Sick Children | Recruiting |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Contact: Milind D. Ronghe, MD 44-141-201-9309 | |
Royal Hospital for Sick Children | Recruiting |
Edinburgh, Scotland, United Kingdom, EH9 1LF | |
Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
United Kingdom, Wales | |
Childrens Hospital for Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk |
Study Chair: | Margaret Childs | Children's Cancer and Leukaemia Group |
Study ID Numbers: | CDR0000350221, SIOP-SIOPEL-4, EU-20336, CCLG-LT-2004-09 |
Study First Received: | February 10, 2004 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00077389 History of Changes |
Health Authority: | Unspecified |
childhood hepatoblastoma stage IV childhood liver cancer |
Liver Neoplasms Anti-Bacterial Agents Liver Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin |
Hepatocellular Carcinoma, Childhood Adjuvants, Immunologic Gastrointestinal Neoplasms Carboplatin Hepatoblastoma Doxorubicin |
Liver Diseases Digestive System Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Carboplatin Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Hepatoblastoma Neoplasms, Complex and Mixed |