AREN0534 | Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
DOI: 10.7937/TCIA.5M9S-6Y97 | Data Citation Required | 130 Views | Image Collection
Location | Species | Subjects | Data Types | Cancer Types | Size | Status | Updated | |
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Kidney | Human | 239 | MR, US, OT, CT, PT | Wilms Tumor | Clinical | Limited, Complete | 2021/11/09 |
Summary
This collection contains data from the Children’s Oncology Group (COG) Clinical Trial NCT00945009, “Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor, " Study Chair: Peter F. Ehrlich, M.D. M.S.C. It was sponsored by NCI and performed by the Children's Oncology Group under study number AREN0534. This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Select patient-level clinical data from this trial is available via the following link: https://nctn-data-archive.nci.nih.gov/node/728. Children with bilateral Wilms tumor account for 5-7% of all patients with Wilms tumor. Certain patients, with syndromes associated with Wilms tumor development, have been identified to be at increased risk for bilateral tumors. Due to an increased risk for renal failure, patients with bilateral disease at presentation are treated with preoperative chemotherapy in order to preserve renal parenchyma. Although this recommendation was made nearly 30 years ago, patients with bilateral tumors have not been formally studied in prior cooperative trials. Recent evidence suggests that survival of these patients is inferior to similar patients with unilateral tumor. This study is designed to improve the survival of these children, while continuing the emphasis on preserving renal function. Patients were enrolled and imaging studies were centrally reviewed to assess for bilateral renal lesions. They were treated with 3-drug induction chemotherapy (vincristine, dactinomycin, and doxorubicin) for 6 or 12 weeks based on radiographic response followed by surgery and further chemotherapy determined by histology. Radiation therapy was provided for postchemotherapy stage III and IV disease. One hundred eighty-nine of 208 patients were evaluable. Four-year EFS and OS were 82.1% (95% CI: 73.5%–90.8%) and 94.9% (95% CI: 90.1%–99.7%. Twenty-three patients relapsed and 7 had disease progression. After induction chemotherapy 163 of 189 (84.0%) underwent definitive surgical treatment in at least 1 kidney by 12 weeks and 39% retained parts of both kidneys. Surgical approaches included: unilateral total nephrectomy with contralateral partial nephrectomy (48%), bilateral partial nephrectomy (35%), unilateral total nephrectomy (10.5%), unilateral partial nephrectomy (4%), and bilateral total nephrectomies (2.5%). This treatment approach including standardized 3-drug preoperative chemotherapy, surgical resection within 12 weeks of diagnosis and response and histology-based postoperative therapy improved EFS and OS and preservation of renal parenchyma compared with historical outcomes for children with bilateral Wilms tumor. Before enrollment, real-time central review of diagnostic imaging, pathology (if obtained), and operative notes confirmed the status of BWT. After 6 weeks, cross-sectional imaging was performed and a tumor response was assigned for each kidney. After 4 chemotherapy cycles (12 weeks), repeat cross sectional imaging was performed and definitive surgery was required. Response was based on the Response Evaluation Criteria in Solid Tumor (RECIST 1.1) modified to include 3 lesions per kidney. Results of the trial have been reported in the following publication:Trial Description
Trial Outcomes
Data Access
This 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 NCT00945009 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 2021/11/09
Title | Data Type | Format | Access Points | Subjects | License | |||
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Images | MR, US, OT, CT, PT | DICOM | Download requires NBIA Data Retriever |
239 | 1,176 | 12,093 | 804,789 | NCTN/NCORP Data Archive License (Without Collaborative Agreement) |
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 (Clinical Data)
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 |
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Ehrlich, P., Chi, Y. Y., Chintagumpala, M. M., Hoffer, F. A., Perlman, E. J., Kalapurakal, J. A., Warwick, A., Shamberger, R. C., Khanna, G., Hamilton, T. E., Gow, K. W., Paulino, A. C., Gratias, E. J., Mullen, E. A., Geller, J. I., Grundy, P. E., Fernandez, C. V., Ritchey, M. L., & Dome, J. S. (2021). Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor (AREN0534) [Data set]. The Cancer Imaging Archive. https://doi.org/10.7937/TCIA.5M9S-6Y97
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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.
Related Publications
Publications by the Dataset Authors
The authors recommended the following as the best source of additional information about this dataset:
Publication Citation |
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Ehrlich, P., Chi, Y. Y., Chintagumpala, M. M., Hoffer, F. A., Perlman, E. J., Kalapurakal, J. A., Warwick, A., Shamberger, R. C., Khanna, G., Hamilton, T. E., Gow, K. W., Paulino, A. C., Gratias, E. J., Mullen, E. A., Geller, J. I., Grundy, P. E., Fernandez, C. V., Ritchey, M. L., & Dome, J. S. (2017). Results of the First Prospective Multi-institutional Treatment Study in Children With Bilateral Wilms Tumor (AREN0534). In Annals of Surgery (Vol. 266, Issue 3, pp. 470–478). Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/sla.0000000000002356 |
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Research Community Publications
TCIA maintains a list of publications that leveraged this dataset. If you have a manuscript you’d like to add please contact TCIA’s Helpdesk.