Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered

Undifferentiated embryonal sarcoma of the liver is the 3rd most common malignant liver tumor after hepatoblastoma and hepatocellular carcinoma with a peak incidence between 6 and 10 years of age. Historically, it is a tumor treated only by surgery with a poor prognosis. In the last decade, the combination of more intensive chemotherapy and, more randomly, radiotherapy, has significantly improved the survival rate of these patients. Due to its low incidence, there are few series reported in the literature and to date there is no specific treatment protocol for the management of these tumors.

It seems appropriate to review the management of these tumors in France in order to discuss the best therapeutic strategy.

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Key information

Conditions

Hepatic Sarcoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Hepatoblastoma Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Sarcoma Urogenital Abnormalities Urogenital Diseases

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any patient aged 0 to 25 on the date of inclusion in the study
Treatment carried out in France (included in NRSTS 2005, in the childhood cancer registry or in an SFCE center)
Start of treatment from 01/01/2008 to 31/12/2018
Diagnosis of undifferentiated embryonal sarcoma of the liver defined by a compatible histological analysis
Adult subject who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
Minor subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria

Refusal to participate in this research
Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET
Absence of histological and/or molecular documentation.

Treatment and study plan

Primary outcomes

Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received

Time frame: 3 years after treatment

the primary endpoint is event-free survival (progression, death, relapse) at 3 years.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Undifferentiated Embryonal Sarcoma of the Liver

Acronym: SARCOM

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 7, 2022
Registry last updated: Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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