{"id":5680,"date":"2023-09-04T03:17:29","date_gmt":"2023-09-04T03:17:29","guid":{"rendered":"https:\/\/cm.vastapps.dev\/tcia-collection\/ahep0731\/"},"modified":"2023-09-13T12:02:46","modified_gmt":"2023-09-13T12:02:46","slug":"ahep0731","status":"publish","type":"tcia_collection","link":"https:\/\/cm.vastapps.dev\/tcia-collection\/ahep0731\/","title":{"rendered":"AHEP0731"},"featured_media":7669,"template":"","citation-tax":[],"cancer_types":["Hepatoblastoma"],"citations":[4620,4621,2925],"collection_doi":"10.7937\/F2DB-8826","collection_download_info":"This is a\u00a0limited access<\/strong><\/u>\u00a0data set.\u00a0To request access please register an account on the\u00a0NCTN Data Archive<\/a>\u00a0and use the\u00a0\"Request Data\" link in the left side menu.\u00a0 Follow the on screen instructions, and enter\u00a0NCT00980460<\/strong>\u00a0<\/strong>when asked which trial you want to request.\u00a0\u00a0In step 2 of the Create Request form, be sure to select \u201cImaging Data Requested\u201d. Please contact\u00a0NCINCTNDataArchive@mail.nih.gov<\/a>\u00a0for any questions about access requests.","collection_downloads":[5243],"full_export":"

Summary<\/h1>

<\/span>This collection contains data from the National Cancer Institute Clinical Trial NCT00980460<\/a><\/span>, "<\/span>Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer<\/span>." It was sponsored by NCI's Children\u2019s Oncology Group (COG) under study number <\/span>AHEP0731. <\/span>This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. <\/span>Select individual patient-level data from this trial can be requested from the NCTN\/NCORP Data Archive.<\/span><\/p>

Trial Description<\/strong><\/p>

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.<\/p>

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\u20136 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.\u00a0 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.\u00a0 Patients were staged for risk classification using the Children\u2019s Oncology Group staging guidelines before the initiation of chemotherapy, with stage IV indicating metastatic disease. \u00a0Pretreatment 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.\u00a0 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.<\/p>

For Low-Risk patients CT chest was used for metastatic tumor response assessment.\u00a0 Abdominal Ultrasound was obtained at baseline.\u00a0 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.<\/p>

Trial Outcomes <\/strong><\/p>

Results of the trial for Low-Risk patients have been reported in the following publication:<\/p>

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\u2019Neill, 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\u2019s Oncology Group, multicentre, phase 3 trial. The Lancet Oncology, 20(5), 719\u2013727<\/span>. DOI:<\/span>\u00a0https:\/\/doi.org\/10.1016\/s1470-2045(18)30895-7<\/a>.\u00a0Epub 2019 Apr 8. Erratum in: Lancet Oncol. 2019 May;20(5):e243. PMID: 30975630; PMCID: PMC6499702<\/span><\/span>. Epub 2019 Apr 8. Erratum in: Lancet Oncol. 2019 May;20(5):e243. PMID: 30975630; PMCID: PMC6499702.<\/p>

Acknowledgements<\/span><\/h3>

We would like to acknowledge the individuals and institutions that have provided data for this collection:<\/p>

<\/p>