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Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Unique Dataset IDNCT00980460
SponsorNational Cancer InstituteData ProviderNational Cancer InstituteTotal Study Enrolled Patients253RandomizationNoPubMed (PMID)28211941.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeSurgery, Other, DrugDataset TypeOther

Clinical Trial Title

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Trial Summary and Conditions

This 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.

Data Summary

See Data Dictionary.

Study Objectives

PRIMARY OBJECTIVES: I. To estimate the event-free survival (EFS) in children with stage I (non-pure fetal histology [PFH], non-small cell undifferentiated [SCU]) and stage II (non-SCU) hepatoblastoma treated with surgical resection followed by 2 cycles of cisplatin, fluorouracil, and vincristine sulfate (C5V). II. To determine the feasibility and toxicity of adding doxorubicin (doxorubicin hydrochloride) to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma. III. To estimate the response rate to vincristine (vincristine sulfate), irinotecan (irinotecan hydrochloride), and temsirolimus in previously untreated children with high-risk, metastatic hepatoblastoma. IV. To determine whether timely (between diagnosis and end of second cycle of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma. V. To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials. SECONDARY OBJECTIVES: I. To estimate the EFS of patients with stage I PFH treated with surgery alone. II. To determine whether orthotopic liver transplantation (OLT) can be accomplished after successful referral and completion of 4 cycles of initial chemotherapy. III. To estimate the 2-year EFS for patients once identified as candidates for possible OLT, the 2-year EFS for patients referred to a transplant center that are resected without OLT, and the 2-year EFS for patients referred to a transplant center who receive OLT. IV. To register children with hepatoblastoma who receive OLT with PLUTO (Pediatric Liver Unresectable Tumor Observatory), an international cooperative registry for children transplanted for liver tumors. V. To determine if pretreatment extent of disease (PRETEXT) grouping can predict tumor resectability. VI. To monitor the concordance between institutional assessment of PRETEXT grouping and PRETEXT grouping as performed by expert panel review. VII. To estimate the proportion of stage IV patients who have surgical resection of metastatic pulmonary lesions. VIII. To determine the proportion and estimate the EFS of patients with potentially poor prognostic factors including alpha fetoprotein (AFP) < 100 ng/mL at diagnosis, microscopic positive surgical margins, surgical complications, multifocal tumors, microscopic vascular invasion, macrotrabecular histologic subtype, and SCU histologic subtype.

Outcome Measures

Primary Outcome Measures: 1. Event-free survival; 2. Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 5.0; 3. Rate of death; 4. Disease status at the end of 2 courses of therapy. Secondary Outcome Measures: 1. Feasibility of referral for liver transplantation.

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00980460-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.

Available Downloads: NCT00980460-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00980460-D1-Data-Dictionary_2.pdf

DATA: NCT00980460-D1-Dataset_1.csv


Available Downloads: NCT00980460-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00980460-D2-Data-Dictionary_2.pdf

DATA: NCT00980460-D2-Dataset_1.csv


Available Downloads: NCT00980460-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00980460-D3-Data-Dictionary_2.pdf

DATA: NCT00980460-D3-Dataset_1.csv


Available Downloads: NCT00980460-D4

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00980460-D4-Data-Dictionary_3.pdf

DATA: NCT00980460-D4-Dataset_1.CSV


Available Downloads: NCT00980460-D5

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00980460-D5-Data-Dictionary_2.pdf

DATA: NCT00980460-D5-Dataset_1.csv