Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02557750|
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : December 28, 2017
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2018|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557750
|Assiut, Egypt, 71515|
|Contact: Ahmed M. Morsy, MD +2 01003314522 email@example.com|
|Principal Investigator: Ahmed M. Morsy, MD|
|Principal Investigator: Khalid M. Rezk, MD|
|Principal Investigator: Ameer M. Abuelgheet, MD|