National Cancer Institute Clinical Trial NCT00980460This collection contains data from the , "Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer." It was sponsored by NCI's Children’s Oncology Group (COG) under study number AHEP0731. This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
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.
Hepatoblastoma treatment with curative intent requires surgical resection, but only about a third of newly diagnosed patients with hepatoblastoma have resectable disease at diagnosis. Patients who have upfront resection typically receive a total of 4–6 cycles of adjuvant chemotherapy post-surgery, with the combination of cisplatin, fluorouracil, and vincristine. The aim is to investigate whether event-free survival in children with hepatoblastoma who had complete resection at diagnosis could be maintained with two cycles of adjuvant chemotherapy. This multicentre, phase 3 trial was designed to test a risk-based treatment approach for children with hepatoblastoma, to diminish toxicity in low-risk patients, improve survival in intermediate-risk patients, and identify new agents that may be used in high-risk and recurrent patients. Patients were staged for risk classification using the Children’s Oncology Group staging guidelines before the initiation of chemotherapy, with stage IV indicating metastatic disease. Pretreatment extent of disease (PRETEXT) grouping also was performed at the time of diagnosis and with any subsequent abdominal computed tomography or magnetic resonance imaging and was used to guide the surgical management but was not used for risk classification. The response rate and outcome to the combination of vincristine and irinotecan administered in an upfront window to children newly diagnosed with high-risk hepatoblastoma was determined.
For Low-Risk patients CT chest was used for metastatic tumor response assessment. Abdominal Ultrasound was obtained at baseline. For Intermediate- and High-Risk patients abdominal ultrasound, CT and/or MRI was used for primary tumor response assessment and CT chest for metastatic tumor response assessment.
Results of the trial for Low-Risk patients have been reported in the following publication:
Katzenstein, H. M., Langham, M. R., Malogolowkin, M. H., Krailo, M. D., Towbin, A. J., McCarville, M. B., Finegold, M. J., Ranganathan, S., Dunn, S., McGahren, E. D., Tiao, G. M., O’Neill, A. F., Qayed, M., Furman, W. L., Xia, C., Rodriguez-Galindo, C., & Meyers, R. L. (2019). Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children’s Oncology Group, multicentre, phase 3 trial. The Lancet Oncology, 20(5), 719–727. DOI: https://doi.org/10.1016/s1470-2045(18)30895-7. Epub 2019 Apr 8. Erratum in: Lancet Oncol. 2019 May;20(5):e243. PMID: 30975630; PMCID: PMC6499702. Epub 2019 Apr 8. Erratum in: Lancet Oncol. 2019 May;20(5):e243. PMID: 30975630; PMCID: PMC6499702.
We would like to acknowledge the individuals and institutions that have provided data for this collection:
This is a limited access data set. To request access please register an account on the NCTN Data Archive and use the "Request Data" link in the left side menu. Follow the on screen instructions, and enter NCT00980460 when asked which trial you want to request. In step 2 of the Create Request form, be sure to select “Imaging Data Requested”. Please contact NCINCTNDataArchive@mail.nih.gov for any questions about access requests.
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|Images Size (GB)||84|
De-identification of DICOM dates
De-identification of dates for this dataset uses the DICOM Part 3.15 Annex E standard “Retain Longitudinal With Modified Dates Option” which allows dates to be retained as long as they are modified from the original date. TCIA implements this using a technique which de-identifies the dates while preserving the longitudinal relationship between them. Original dates will be first normalized to 01 January, 1960 and then offset relative to the date of registration for each patient. This normalized date system was chosen in order to make it obvious that the dates are not real, and to make it easy to quickly determine how much time has passed between the date of registration and the patients' related imaging studies.
For example, if the real date of a patient's registration was 03/27/2018 and the original imaging Study Date was 03/29/2018 then the "Days from registration" would be +2 and the anonymized TCIA Study Date would become 01/03/1960.
Insertion of computed "REGISTRATION"/Days offset from registration" value
In addition to modifying the actual date fields in the DICOM header, the "days from registration" values are calculated and stored in the DICOM tag (0012,0052) Longitudinal Temporal Offset from Event with the associated tag (0012,0053) Longitudinal Temporal Event Type set to “REGISTRATION”.
Note: If these DICOM tags are not present, DICOM tag (0012,0050) Clinical Trial Time Point ID with the associated tag (0012,0051) Clinical Trial Time Point Description provides this same information. This inconsistency is due to a change in how dates were handled in the first NCTN trials that were published on TCIA.
Citations & Data Usage Policy
This is a limited access data set. Upon receiving access, you must abide by the terms of your NCTN/NCORP Data Archive’s Data Use Agreement (DUA). You are not allowed to redistribute the data or use it for other purposes. Attribution should include references to the following citations:
Katzenstein, H. M., Langham, M. R., Malogolowkin, M. H., Krailo, M. D., Towbin, A. J., McCarville, M. B., Finegold, M. J., Ranganathan, S., Dunn, S., McGahren, E. D., Tiao, G. M., O’Neill, A. F., Qayed, M., Furman, W. L., Xia, C., Rodriguez-Galindo, C., & Meyers, R. L. (2021). Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus Added to High Risk Stratum Treatment (AHEP0731) [Data set]. The Cancer Imaging Archive. https://doi.org/10.7937/F2DB-8826
Katzenstein, H. M., Langham, M. R., Malogolowkin, M. H., Krailo, M. D., Towbin, A. J., McCarville, M. B., Finegold, M. J., Ranganathan, S., Dunn, S., McGahren, E. D., Tiao, G. M., O’Neill, A. F., Qayed, M., Furman, W. L., Xia, C., Rodriguez-Galindo, C., & Meyers, R. L. (2019). Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children’s Oncology Group, multicentre, phase 3 trial. The Lancet Oncology, 20(5), 719–727. https://doi.org/10.1016/s1470-2045(18)30895-7
Clark K, Vendt B, Smith K, Freymann J, Kirby J, Koppel P, Moore S, Phillips S, Maffitt D, Pringle M, Tarbox L, Prior F. The Cancer Imaging Archive (TCIA): Maintaining and Operating a Public Information Repository, Journal of Digital Imaging, Volume 26, Number 6, December, 2013, pp 1045-1057. DOI: 10.1007/s10278-013-9622-7
Other Publications Using This Data
Version 1 (Current): Updated 2021/03/30
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Images (DICOM, 84 GB)
(Requires NBIA Data Retriever.)
Clinical Data (CSV)