Clinical trial NCT02557750: Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience
Official title: Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatoblastoma
Keywords: Childhood Cancer
Pediatric Oncology
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 35
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cancer patients, those diagnosed with hepatoblastoma, in the period from 2002 January till 2016 January, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients whose age more than 18 years.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 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
measure: Event Free Survival (EFS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
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