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Type(s) of Cancer
Liver
Study Phase
Phase 3
Study Completion Date
June 2020
NCT00980460Uploaded 04-29-2020
Access via NCI by Request
PDS UID: nci-data-413
Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment
Provider Information
Provider Data DescriptionNCT00980460-D1-Dataset (Main) This dataset provides the information for baseline characteristics, response, surgical outcome plus event-free and overall survival for all evaluable patients as reported in the manuscript. Information is only provided for evaluable patients (analysiset = 1). Variables were left blank for the patients who were not evaluable (analysiset = 0). There is one row per patient.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
ConditionsPRETEXT I Hepatoblastoma
PRETEXT II Hepatoblastoma
PRETEXT III Hepatoblastoma
PRETEXT IV Hepatoblastoma
Intervention TypeDrug: Cisplatin
Drug: Dexrazoxane
Drug: Doxorubicin Hydrochloride
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Procedure: Liver Transplantation
Drug: Temsirolimus
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug(s)Drug: Cisplatin
Drug: Doxorubicin Hydrochloride
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Drug: Temsirolimus
Drug: Vincristine Sulfate
Drug: Dexrazoxane
Total Enrolled236
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionHigh-risk group (regimen H) - Experimental
High-risk group (regimen W) - Experimental
Intermediate-risk group (regimen F) - Experimental
Low-risk group (regimen T) - Experimental
Very low-risk group - Experimental
Secondary IDNCI-2011-01975
PubMed (PMID)34874751
30975630
Collaborator(s)N/A
Region(s)United States
Australia
Brazil
Canada
Japan
Puerto Rico
Age Range21 Years and younger (Child, Adult)
Files: NCT00980460-D1
Data DictionaryNCT00980460-D1-Data-Dictionary_2.pdf
DATANCT00980460-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00980460-D2
Data DictionaryNCT00980460-D2-Data-Dictionary_2.pdf
DATANCT00980460-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00980460-D3
Data DictionaryNCT00980460-D3-Data-Dictionary_2.pdf
DATANCT00980460-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00980460-D4
Data DictionaryNCT00980460-D4-Data-Dictionary_3.pdf
DATANCT00980460-D4-Dataset_1.CSV
OTHERREADME.pdf
Files: NCT00980460-D5
Data DictionaryNCT00980460-D5-Data-Dictionary_2.pdf
DATANCT00980460-D5-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00980460-D6
Data DictionaryNCT00980460-D6-Data-Dictionary_1.pdf
DATANCT00980460-D6-Dataset_1.CSV
OTHERREADME.pdf
Files: NCT00980460-D7
Data DictionaryNCT00980460-D7-Data-Dictionary_1.pdf
DATANCT00980460-D7-Dataset_1.CSV
OTHERREADME.pdf
Files: NCT00980460-D8
Data DictionaryNCT00980460-D8-Data-Dictionary_1.pdf
DATANCT00980460-D8-Dataset_1.CSV
OTHERREADME.pdf
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