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title | Data Access |
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| Data AccessThis is a limited access data set. To request access please register an account on the NCTN Data Archive. After logging in, use the "Request Data" link in the left side menu. Follow the on screen instructions, and enter NCT00379340 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. Data Type | Download all or Query/Filter |
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Images , Segmentations, and Radiation Therapy Structures/Doses/Plans (DICOM, XX.X GB) << latter two items only if DICOM SEG/RTSTRUCT/RTDOSE/PLAN exist >> |
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| | Clinical data (CSVlink) | | Genomics (web) | Tcia button generator |
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Localtab |
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title | Detailed Description |
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| Detailed DescriptionImage Statistics |
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Modalities |
| Number of Patients | 606 | Number of Studies | 1150 | Number of Series |
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I. Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (< 2 years of age and < 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk). SECONDARY OBJECTIVES: I. Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker. II. Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only. III. Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse. IV. Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2. OUTLINE: This is a multicenter study. Patients are stratified according to clinical and biological risk factors (very low risk vs standard risk). STRATUM I: (very low-risk disease) Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks. STRATUM II: (standard-risk, stage I or II disease with adverse biological marker) Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks. STRATUM III: (standard-risk, stage III disease) Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks. After completion of study treatment, patients are followed periodically for up to 8 years. Include Page |
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| National Clinical Trials Network (NCTN) Date Handling |
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| National Clinical Trials Network (NCTN) Date Handling |
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Localtab |
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title | Citations & Data Usage Policy |
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| Citations & Data Usage PolicyThis 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: Info |
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| Dix DB, Fernandez CV, Chi YY, Mullen EA, Geller JI, Gratias EJ, Khanna G, Kalapurakal JA, Perlman EJ, Seibel NL, Ehrlich PF, Malogolowkin M, Anderson J, Gastier-Foster J, Shamberger RC, Kim Y, Grundy PE, Dome JS; AREN0532 and AREN0533 study committees. Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children's Oncology Group AREN0532 and AREN0533 Study Report. J Clin Oncol. 2019 Oct 20;37(30):2769-2777. doi: 10.1200/JCO.18.01972. Epub 2019 Aug 26.Fernandez, C. V., Mullen, E. A., Chi, Y.-Y., Ehrlich, P. F., Perlman, E. J., Kalapurakal, J. A., Khanna, G., Paulino, A. C., Hamilton, T. E., Gow, K. W., Tochner, Z., Hoffer, F. A., Withycombe, J. S., Shamberger, R. C., Kim, Y., Geller, J. I., Anderson, J. R., Grundy, P. E., & Dome, J. S. (2018). (Verify authorship & publication citation) |
Info |
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title | Publication Citation |
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| Fernandez CV, C. V., Mullen EA, E. A., Chi YY, Y.-Y., Ehrlich PF, P. F., Perlman EJ, E. J., Kalapurakal JA, J. A., Khanna, G., Paulino AC, A. C., Hamilton TE, T. E., Gow KW, K. W., Tochner, Z., Hoffer FA, F. A., Withycombe JS, J. S., Shamberger RC, R. C., Kim, Y., Geller JI, J. I., Anderson JR, J. R., Grundy PE, P. E., Dome JS& Dome, J. S. (2018). Outcome and Prognostic Factors in Stage III Favorable-Histology Wilms Tumor: A Report From the Children's Children’s Oncology Group Study AREN0532. J Clin Oncol. 2018 Jan 20;36(3):254-261. doi: 10.1200/JCO.2017.73.7999. Epub 2017 Dec 6. Erratum in: J Clin Oncol. 2019 Oct 10;37(29):2710. | Info |
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| lFernandez CV, Perlman EJ, Mullen EA, Chi YY, Hamilton TE, Gow KW, Ferrer FA, Barnhart DC, Ehrlich PF, Khanna G, Kalapurakal JA, Bocking T, Huff V, Tian J, Geller JI, Grundy PE, Anderson JR, Dome JS, Shamberger RC. Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor: A Report From Children's Oncology Group AREN0532. Ann Surg. 2017 Apr;265(4):835-840. doi: 10.1097/SLA.0000000000001716.In Journal of Clinical Oncology (Vol. 36, Issue 3, pp. 254–261). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2017.73.7999 |
Info |
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| 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 , Volume (Vol. 26, Number Issue 6, December, 2013, pp 1045-1057. DOI: , pp. 1045–1057). Springer Science and Business Media LLC. https://doi.org/10.1007/s10278-013-9622-7 |
Other Publications Using This DataTCIA maintains a list of publications which leverage TCIA data. If you have a manuscript you'd like to add please contact the TCIA Helpdesk. |
Localtab |
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