Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02557750
Collaborator
(none)
35
1
81
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience
    Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients whose age less than 19 years.

    • Patients diagnosed with hepatoblastoma.

    Exclusion Criteria:
    • Patients whose age more than 18 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02557750
    Other Study ID Numbers:
    • Comb Mod Hepatoblastoma SECI
    First Posted:
    Sep 23, 2015
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2022