Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
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ClinicalTrials.gov Identifier: NCT00077389 |
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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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 |

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 |

- Rate of complete remission after completion of study therapy
- 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 |
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

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

Study Chair: | Margaret Childs | Children's Cancer and Leukaemia Group |
ClinicalTrials.gov Identifier: | NCT00077389 |
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 |
childhood hepatoblastoma stage IV childhood liver cancer |
Liver Neoplasms Hepatoblastoma Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Cisplatin |
Carboplatin Doxorubicin Liposomal doxorubicin Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |