Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

Recruiting

• Conditions: Hepatoblastoma

• Registration Number: NCT02557750
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to retrospectively investigate the effect of combined modality treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance with the experience at the pediatric oncology department at South Egypt Cancer Institute.

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 Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2016-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-09
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients whose age less than 19 years.
• Patients diagnosed with hepatoblastoma.

Exclusion Criteria

• Patients whose age more than 18 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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 death from any cause
Event Free Survival (EFS)	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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt