Clinical Trial: Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

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 Summary:

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.


Sponsor: Assiut University

Current Primary Outcome:

  • 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 ]
    Time from the date of initiation of treatment until death from any cause
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assiut University

Dates:
Date Received: September 22, 2015
Date Started: January 2016
Date Completion: June 2017
Last Updated: February 24, 2017
Last Verified: February 2017