NCT00980460
Clinical Trial Information
Trial Number: NCT00980460 (ClinicalTrials.gov)
Disease Type:
- Gastrointestinal Neoplasm - Liver and Hepatobiliary Cancer
Trial Title:
Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment
Study ID:
AHEP0731
Images are available?:
Yes
Imaging data can be requested via the NCTN/NCORP Data Archive. To view imaging data details before requesting data here, visit:
Is this a NCI-MATCH Trial?:
No
Datasets Linked to Trial
| Title | Description |
|---|---|
| NCT00980460-D11 | There are two data submissions associated with PMID 37073741: NCT00980460-D10 through -D11. 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 | There are two data submissions associated with PMID 37073741: NCT00980460-D10 through -D11. This dataset, NCT00980460-D10, 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 data file. There is one row for each patient. |
| NCT00980460-D9 | NCT00980460-D9 Dataset Description: NCT00980460 – There is one data submission associated with PMID 35810020: NCT00980460-D9 provides the information for the 8 very low-risk hepatoblastoma patients who were enrolled on AHEP0731. The dataset provides the information of 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 data file. There is one row for each patient. |
| NCT00980460-D8 | There are three data submissions associated with PMID 34762296: NCT00980460-D6 through -D8. 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 data file. The number of rows per patient is dependent on the number of adverse events submitted. |
| NCT00980460-D7 | There are three data submissions associated with PMID 34762296: NCT00980460-D6 through -D8. 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 data file, multiple rows per patient, with proportion of target dose delivered for cisplatin, 5-FU, doxorubicin and vincristine. |
| NCT00980460-D6 | There are three data submissions associated with PMID 34762296: NCT00980460-D6 through -D8. This dataset, NCT00980460-D6, 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 and all primary analyses reported in the manuscript. There is one row per patient. There are 105 patients in this data file. |
| NCT00980460-D5 | This dataset provides the information for the specific toxicities that occurred during protocol therapy. Evaluable patients are defined in the main data set (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 | This dataset provides the information for baseline characteristics, disease stage, surgical outcome event-free survival and overall survival. Information is only provided for eligible patients (analysis01 = 1). There is one row per patient. |
| NCT00980460-D3 | NCT00980460-D3-Dataset (Adverse Events specifically nausea and neuropathy during cycles 1-2) This dataset provides the information for nausea and neuropathy that occurred during cycles 1 and 2 for evaluable patients. Evaluable patients are defined in the main data set (analysiset = 1). There is one row per patient. |
| NCT00980460-D2 | NCT00980460-D2-Dataset (Adverse Events during all cycles 1-10) This dataset provides the information for the specific toxicities that occurred during cycles 1 through 10 for evaluable patients. Evaluable patients are defined in the main data set (analysiset = 1). There are multiple rows per patient depending on whether they had multiple cycles submitted. |
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