Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
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| ClinicalTrials.gov Identifier: NCT00077389 |
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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
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Sponsor:
University of Leicester
Information provided by:
National Cancer Institute (NCI)
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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 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
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
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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
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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
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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):
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childhood hepatoblastoma stage IV childhood liver cancer |
Additional relevant MeSH terms:
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Liver Neoplasms Hepatoblastoma Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type |
Carboplatin Doxorubicin Liposomal doxorubicin Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |