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NCTN: Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment (AHEP0731)

Study ID: AHEP0731

NCT Number: NCT00980460

Children's Oncology Group (COG)

Submitted in collaboration with the NCTN/NCORP Data Archive

Trial Title: NCTN: Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment (AHEP0731)

Trial Description: 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.

Clinical data presented in the following publication(s):

Disease type(s): Gastrointestinal Neoplasm - Liver and Hepatobiliary Cancer

Clinical Dataset(s) included:

• NCT00980460-D1 (PMID 28211941): There are three datasets (-D1 through -D3) for the AHEP0731 publication 28211941, reporting on the high-risk cohort who received Vincristine and Irinotecan. This dataset provides the information for baseline characteristics, PRETEXT grouping, surgery details, changes in AFP levels, response, relapse site, and 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. NCT00980460-D2 and -D3 contain toxicity data for this high-risk cohort.

• NCT00980460-D2 (PMID 28211941): There are three datasets (-D1 through -D3) for the AHEP0731 publication 28211941, reporting on the high-risk cohort who received Vincristine and Irinotecan. This dataset provides the information for the specific toxicities that occurred during cycles 1 through 10 for evaluable patients. Evaluable patients are defined in NCT00980460-D1 (analysiset = 1). There are multiple rows per patient depending on whether they had multiple cycles submitted. NCT00980460-D1 contains baseline characteristics and outcome data and NCT00980460-D3 contains nausea and neuropathy toxicity events for this high-risk cohort.

• NCT00980460-D3 (PMID 28211941): There are three datasets (-D1 through -D3) for the AHEP0731 publication 28211941, reporting on the high-risk cohort who received Vincristine and Irinotecan. This dataset provides the information for nausea and neuropathy that occurred during cycles 1 and 2 for evaluable patients. Evaluable patients are defined in NCT00980460-D1 (analysiset = 1). There is one row per patient. NCT00980460-D1 contains baseline characteristics and outcome data and NCT00980460-D2 contains toxicities from cycles 1 through 10 for this high-risk cohort.

• NCT00980460-D4 (PMID 30975630): There are two datasets (-D4 and -D5) for the AHEP0731 publication 30975630, reporting on the low-risk cohort. This dataset provides the information for eligibility, baseline characteristics, disease stage, PRETEXT grouping, surgery details, changes in AFP levels, surgical outcome event-free survival, and overall survival. Information is only provided for eligible patients (analysis01 = 1). There is one row per patient. NCT00980460-D5 contains toxicity data for the low-risk cohort.

• NCT00980460-D5 (PMID 30975630): There are two datasets (-D4 and -D5) for the AHEP0731 publication 30975630, reporting on the low-risk cohort. This dataset provides the information for the specific toxicities that occurred during protocol therapy. Evaluable patients are defined in NCT00980460-D4 (analysis01 = 1). There is one row per patient/toxicity term. Each row has the maximum grade of the particular toxicity term observed during the patient's protocol treatment. NCT00980460-D4 contains baseline characteristics and outcome data for the low-risk cohort.

• NCT00980460-D6 (PMID 34762296): There are three datasets (-D6 through -D8) for the AHEP0731 publication 34762296, reporting on the intermediate-risk cohort. This dataset provides the information for all intermediate-risk patients who were enrolled on AHEP0731, up to 02/10/2020, both eligible and ineligible. It contains data presented in Figure 1 (the consort diagram), Figure 2 (Event-Free and Overall Survival of Patients with Unresectable non-Metastatic Hepatoblastoma), Table 1 (Patient Demographics for Patients with Intermediate-risk Hepatoblastoma), and the baseline characteristics, relapse sites, PRETEXT grouping, changes in AFP levels, surgery type, and evaluability for toxicity analyses. There is one row per patient. There are 105 patients in this dataset. NCT00980460-D7 contains mean percentage of target dose delivered data and NCT00980460-D8 contains toxicity data for the intermediate-risk cohort.

• NCT00980460-D7 (PMID 34762296): There are three datasets (-D6 through -D8) for the AHEP0731 publication 34762296, reporting on the intermediate-risk cohort. This dataset, NCT00980460-D7, provides the information for all eligible intermediate-risk patients enrolled on AHEP0731, up to 02/10/2020. It contains data on the mean percentage of the target dose delivered for chemotherapy. There are 195 observations in this dataset, multiple rows per patient, with proportion of target dose delivered for cisplatin, 5-FU, doxorubicin and vincristine. NCT00980460-D6 contains baseline characteristics and outcome data and NCT00980460-D8 contains toxicity data for the intermediate-risk cohort.

• NCT00980460-D8 (PMID 34762296): There are three datasets (-D6 through -D8) for the AHEP0731 publication 34762296, reporting on the intermediate-risk cohort. This dataset, NCT00980460-D8, provides the information for adverse events recorded for all eligible intermediate-risk patients enrolled on AHEP0731, up to 02/10/2020. It contains data on Table 2 (Toxicities (Grade 3, 4, and 5) of Patients with Intermediate-risk Hepatoblastoma), and the information on adverse events and toxicities in the Results section of the manuscript. There are 723 observations, one for each toxicity type per patient per cycle, included in this dataset. The number of rows per patient is dependent on the number of adverse events submitted. NCT00980460-D6 contains baseline characteristics and outcome data and NCT00980460-D7 contains mean percentage of target dose delivered data for the intermediate-risk cohort.

• NCT00980460-D9 (PMID 35810020): There is one dataset for the AHEP0731 publication 35810020, reporting on the very low-risk cohort. NCT00980460-D9 provides the information for the 8 very low-risk hepatoblastoma patients who were enrolled on AHEP0731. The dataset contains baseline characteristics, α-fetoprotein levels, pretext group, vascular involvement, surgical details and tumor histology from local and central review, as well as outcome data as reported in the manuscript. It is used to generate all the tables in the manuscript, (Table 1. Patient Characteristics for Children with Very Low-Risk Hepatoblastoma and Table 2. Clinical and Surgical Traits for Children with Very Low-Risk Hepatoblastoma), and Figure 2. Event-free Survival and Overall Survival of Patients with Very Low Risk Hepatoblastoma Resected at Diagnosis. There are 8 patients in this dataset. There is one row for each patient.

• NCT00980460-D10 (PMID 37073741): There are two datasets (-D10 and -D11) for the AHEP0731 publication 37073741, reporting on the high-risk cohort who received Vincristine, Irinotecan, and Temsirolimus. This dataset, NCT00980460-10, provides the information of baseline characteristics, α-fetoprotein levels, α-fetoprotein and RECIST response, as well as details on recurrent disease, metastatic disease, and surgery for the 40 high-risk hepatoblastoma patients who were enrolled on AHEP0731. Tumor histologic information and pretext classification from central review are also included as well as outcome data as reported in the manuscript. It is used to generate Table 1. Characteristics of eligible patients with high-risk hepatoblastoma treated with upfront vincristine/irinotecan/temsirolimus window therapy, Table 2. Response of patients to upfront vincristine/irinotecan/temsirolimus window therapy, Table 3. Surgical outcomes for patients treated with vincristine/irinotecan/temsirolimus upfront window therapy, Figure 1. Alpha-fetoprotein (AFP) decline after two cycles of VIT (vincristine/irinotecan/temsirolimus) therapy, and Figure 2. Event-free and overall survival of patients with high-risk hepatoblastoma treated with VIT (vincristine/irinotecan/temsirolimus). There are 40 patients in this dataset. There is one row for each patient. NCT00980460-D11 contains toxicity data for this high-risk cohort.

• NCT00980460-D11 (PMID 37073741): There are two datasets (-D10 and -D11) for the AHEP0731 publication 37073741, reporting on the high-risk cohort who received Vincristine, Irinotecan, and Temsirolimus. This dataset, NCT00980460-D11, provides all grade 3 and 4 adverse events while on protocol therapy for the 36 eligible high-risk hepatoblastoma patients enrolled on AHEP0731 (Supplemental Table 3. Selected Grade 3 and 4 Toxicities) as well as selected grade 3 and 4 adverse events while on protocol therapy (Table 4. Selected grade 3 and 4 toxicities for patients treated with vincristine/irinotecan/temsirolimus upfront window therapy followed by cisplatin/5-fluorouracil/vincristine/doxorubicin.). The number of rows per patient is dependent on the number of adverse events submitted. NCT00980460-D10 contains baseline characteristics and outcome data for this high-risk cohort.

You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).