TriangleNCT00077389 · CITED IN SOURCE DOCUMENTS
Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- UNKNOWN
- Registry last update
- 2014-06-24
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- maximum Age
- 17 Years
- sex
- ALL
- std Ages
- CHILD
Treatment arms and interventions
- interventions
- name
- carboplatin
- type
- DRUG
- name
- cisplatin
- type
- DRUG
- name
- doxorubicin hydrochloride
- type
- DRUG
- name
- adjuvant therapy
- type
- PROCEDURE
- name
- conventional surgery
- type
- PROCEDURE
- name
- neoadjuvant therapy
- type
- PROCEDURE
Study design
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 57
- type
- ESTIMATED
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Rate of complete remission after completion of study therapy
- secondary Outcomes
- measure
- Complete resection rate
- measure
- Response rate to preoperative chemotherapy
- measure
- Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy
- measure
- Overall survival
- measure
- Event-free survival
Full study description
- 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.
- detailed Description
- 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.
Source references
- references
- citation
- 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
- type
- DERIVED
- citation
- 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-b1186f5fd48f5afb0e7c
- requested nct id
- NCT00077389
- primary nct id
- NCT00077389
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- 4c58da315c011c9fce366d0b3d1622f2faba78e750ad4739f89f83e6f040e2ad
- payload sha256
- b087defe57351a829460f1d92a7950e9bbc6bad342b80d3b06e658b1d96755af
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-b1186f5fd48f5afb0e7c
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00077389
- occurrences
- context exact
- ses, 50% were able to achieve complete remission of metastases with chemotherapy alone (without lung surgery).</li></ul></div></li><li><a href="/clinicaltrials/NCT00077389">SIOPEL-4 (NCT00077389)</a> was a multinational feasibility trial of dose-dense cisplatin/doxorubicin chemotherapy and radical surgery for a group of children
- end
- 195643
- exact text
- NCT00077389
- start
- 195632
- context exact
- chieve complete remission of metastases with chemotherapy alone (without lung surgery).</li></ul></div></li><li><a href="/clinicaltrials/NCT00077389">SIOPEL-4 (NCT00077389)</a> was a multinational feasibility trial of dose-dense cisplatin/doxorubicin chemotherapy and radical surgery for a group of children with high-risk hepatobl
- end
- 195666
- exact text
- NCT00077389
- start
- 195655
- context exact
- static hepatoblastoma resulted from treatment with dose-dense cisplatin and doxorubicin, although significant toxicity was also noted (<a href="/clinicaltrials/NCT00077389">SIOPEL-4 [NCT00077389]</a> trial).[<a href="#cit/section_7.74">74</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810033&version=HealthProfessional&
- end
- 201312
- exact text
- NCT00077389
- start
- 201301
- context exact
- esulted from treatment with dose-dense cisplatin and doxorubicin, although significant toxicity was also noted (<a href="/clinicaltrials/NCT00077389">SIOPEL-4 [NCT00077389]</a> trial).[<a href="#cit/section_7.74">74</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810033&version=HealthProfessional&language=English" oncl
- end
- 201335
- exact text
- NCT00077389
- start
- 201324
- context exact
- </p> <div class="pdq-content-list"><ol id="_1937"><li>A subset of 39 patients presenting with metastases were enrolled in the <a href="/clinicaltrials/NCT00077389">SIOPEL-4 (NCT00077389)</a> trial, a multinational feasibility trial of dose-dense cisplatin/doxorubicin chemotherapy and radical surgery for a group of childr
- end
- 203716
- exact text
- NCT00077389
- start
- 203705
- context exact
- ="pdq-content-list"><ol id="_1937"><li>A subset of 39 patients presenting with metastases were enrolled in the <a href="/clinicaltrials/NCT00077389">SIOPEL-4 (NCT00077389)</a> trial, a multinational feasibility trial of dose-dense cisplatin/doxorubicin chemotherapy and radical surgery for a group of children with high-risk hepat
- end
- 203739
- exact text
- NCT00077389
- start
- 203728
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/c6f6bd763c84dfcedd.html
- source file sha256
- 4c58da315c011c9fce366d0b3d1622f2faba78e750ad4739f89f83e6f040e2ad
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:21:58.686488+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 0554ab85bc4581c08d95746555b5b04b1d456363c50e269b0dd2d07b4cf008c0
- source title
- Childhood Liver Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: January 6, 2025
- datetime
- 2025-01-06T12:00:00Z
- display
- January 6, 2025
Preserved source evidence · Not medical advice