- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557750
Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience
Study Overview
Status
Conditions
Detailed Description
Background:
Hepatoblastoma (HB) is the most common malignant liver tumor in children, with an incidence of 0.7 to 1 per million children <15 years of age. Till 1970s, surgery was the primary modality of treatment of HB. Unfortunately, up to 60% of the patients present in an unresectable stage. Later, the chemo- responsiveness of the tumor was demonstrated which led to the incorporation of adjuvant chemotherapy with cisplatinum and doxorubicin in the treatment of HB. International Society of Pediatric Oncology (SIOP) pioneered the concept of neoadjuvant chemotherapy in the management of HB.
Patients & Methods:
In the period from 2002 January till 2016 January, retrieval & analysis of the medical records of pediatric patients with hepatoblastoma will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. After pathologic confirmation of the diagnosis, these data will be categorized according to patients' demographics, presenting features, laboratory studies, including tumor markers & histologic subtype, radiographic evaluation, disease staging, treatment course given, and subsequent treatment outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Recruiting
- Assiut University
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Contact:
- Ahmed M. Morsy, MD
- Phone Number: +2 01003314522
- Email: ahmedmohammed7829@yahoo.com
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Principal Investigator:
- Ahmed M. Morsy, MD
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Principal Investigator:
- Khalid M. Rezk, MD
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Principal Investigator:
- Ameer M. Abuelgheet, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients whose age less than 19 years.
- Patients diagnosed with hepatoblastoma.
Exclusion Criteria:
- Patients whose age more than 18 years.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
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Time from the date of initiation of treatment until death from any cause
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Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
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Event Free Survival (EFS)
Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
|
Time from the date of initiation of treatment until disease progression, or death for any reason.
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Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bu, M., D. Terrada, et al. (2006).
- Douglass EC, Reynolds M, Finegold M, Cantor AB, Glicksman A. Cisplatin, vincristine, and fluorouracil therapy for hepatoblastoma: a Pediatric Oncology Group study. J Clin Oncol. 1993 Jan;11(1):96-9. doi: 10.1200/JCO.1993.11.1.96.
- Exelby PR, Filler RM, Grosfeld JL. Liver tumors in children in the particular reference to hepatoblastoma and hepatocellular carcinoma: American Academy of Pediatrics Surgical Section Survey--1974. J Pediatr Surg. 1975 Jun;10(3):329-37. doi: 10.1016/0022-3468(75)90095-0.
- Mann JR, Kasthuri N, Raafat F, Pincott JR, Parkes SE, Muir KR, Ingram LC, Cameron AH. Malignant hepatic tumours in children: incidence, clinical features and aetiology. Paediatr Perinat Epidemiol. 1990 Jul;4(3):276-89. doi: 10.1111/j.1365-3016.1990.tb00651.x.
- Ortega JA, Krailo MD, Haas JE, King DR, Ablin AR, Quinn JJ, Feusner J, Campbell JR, Lloyd DA, Cherlow J, et al. Effective treatment of unresectable or metastatic hepatoblastoma with cisplatin and continuous infusion doxorubicin chemotherapy: a report from the Childrens Cancer Study Group. J Clin Oncol. 1991 Dec;9(12):2167-76. doi: 10.1200/JCO.1991.9.12.2167.
- Pritchard J, Brown J, Shafford E, Perilongo G, Brock P, Dicks-Mireaux C, Keeling J, Phillips A, Vos A, Plaschkes J. Cisplatin, doxorubicin, and delayed surgery for childhood hepatoblastoma: a successful approach--results of the first prospective study of the International Society of Pediatric Oncology. J Clin Oncol. 2000 Nov 15;18(22):3819-28. doi: 10.1200/JCO.2000.18.22.3819.
- Quinn JJ, Altman AJ, Robinson HT, Cooke RW, Hight DW, Foster JH. Adriamycin and cisplatin for hepatoblastoma. Cancer. 1985 Oct 15;56(8):1926-9. doi: 10.1002/1097-0142(19851015)56:83.0.co;2-g.
- von Schweinitz D, Byrd DJ, Hecker H, Weinel P, Bode U, Burger D, Erttmann R, Harms D, Mildenberger H. Efficiency and toxicity of ifosfamide, cisplatin and doxorubicin in the treatment of childhood hepatoblastoma. Study Committee of the Cooperative Paediatric Liver Tumour Study HB89 of the German Society for Paediatric Oncology and Haematology. Eur J Cancer. 1997 Jul;33(8):1243-9. doi: 10.1016/s0959-8049(97)00095-6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Comb Mod Hepatoblastoma SECI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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