AHEP0731 | Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

DOI: 10.7937/F2DB-8826 | Data Citation Required | Image Collection

Location	Species	Subjects	Data Types	Cancer Types	Size	Supporting Data	Status	Updated
Liver	Human	80	CT, MR, US	Hepatoblastoma	84.48GB	Clinical	Limited, Complete	2021/03/30

Summary

This collection contains data from the National Cancer Institute Clinical Trial NCT00980460, "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.

Trial Description

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.

Trial Outcomes

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.

Data Access

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.

Version 1: Updated 2021/03/30

Title	Data Type	Format	Access Points	Subjects	Studies	Series	Images	License
Images	US, CT, MR	DICOM	Download (84.48gb) Search Download requires NBIA Data Retriever	80	303	2,074	156,809

Additional Resources for this Dataset

The National Cancer Institute (NCI) has created a centralized, controlled-access database, called the NCTN/NCORP Data Archive, for storing and sharing datasets generated from clinical trials of the National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). Clinical data from the participants in this trial can be found at:

NCTN/NCORP Data Archive

Citations & Data Usage Policy

Data Citation Required: Users must abide by the TCIA Data Usage Policy and Restrictions. Attribution must include the following citation, including the Digital Object Identifier:

Data Citation

Detailed Description

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.

Acknowledgements

We would like to acknowledge the individuals and institutions that have provided data for this collection:

Other Publications Using this Data

TCIA maintains a list of publications which leverage TCIA data. If you have a manuscript you’d like to add please contact the TCIA Helpdesk.

Publication Citation

TCIA Citation

Clark, K., Vendt, B., Smith, K., Freymann, J., Kirby, J., Koppel, P., Moore, S., Phillips, S., Maffitt, D., Pringle, M., Tarbox, L., & Prior, F. (2013). The Cancer Imaging Archive (TCIA): Maintaining and Operating a Public Information Repository. In Journal of Digital Imaging (Vol. 26, Issue 6, pp. 1045–1057). Springer Science and Business Media LLC. https://doi.org/10.1007/s10278-013-9622-7

Analysis Results Using This Collection

AHEP0731-Tumor-Annotations

AHEP0731