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  • Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor (AREN0533)

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Summary

Participants are being asked to take part in this clinical trial, a type of research study, because the participants have a Wilms Tumor cancer.

Primary Objectives

To determine whether delivery of proton beam radiation to a conformal reduced target volume in the flank allows normal flank growth compared to the contralateral untreated side and non-irradiated patients.

Secondary Objectives

To deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients with Stage V (bilateral Wilms tumor) and specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields.

Exploratory Objectives

  • Study the feasibility of sparing the residual kidney, spine and liver in patients requiring whole abdomen radiation therapy using either a proton beam treatment technique or intensity-modulated radiation therapy ( IMRT) photon based technique.
  • Study the feasibility of delivering whole lung radiation therapy with proton beams with the goals of sparing the developing breast tissue, heart structures, thyroid and liver.
  • Develop simultaneous xenografts and organoid models from the same starting material to study Wilms tumor biology and compare responses to chemotherapeutic agents.
  • Define the evolution of organ specific (kidney, liver, pancreas, etc.) abnormalities (laboratory studies) as an early marker of possible late end organ damage and their relationship to radiation.
  • Study and evaluate impact of proton therapy on the musculoskeletal system and physical performance and compare with photon therapy cases treated with classical treatment fields.
  • Assess CTC-AE and Pediatric Patient Reported Outcomes during radiation and in follow-up, correlating with disease, treatment and patient variables.
  • Correlate quantitative MRI values, including apparent diffusion coefficient (ADC) values, with histopathology findings post-surgery in children with (bilateral) Wilms.
  • Assess daily variations in proton range along each treatment beam using standard pre-treatment cone beam CT or on-treatment MR.





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 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 TypeDownload all or Query/Filter

Images, Segmentations, and Radiation Therapy Structures/Doses/Plans (DICOM, XX.X GB)



   

(Download requires the NBIA Data Retriever)

Tissue Slide Images (SVS, XX.X GB)
Clinical data (CSV)
Genomics (web)

Click the Versions tab for more info about data releases.

Please contact help@cancerimagingarchive.net  with any questions regarding usage.

Detailed Description

Image Statistics


Modalities

Primarily CT,MR

Number of Patients

296

Number of Studies

1510

Number of Series


Number of Images


Images Size (GB)

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:

Data Citation

DOI goes here. Create using Datacite with information from Collection Approval form

Publication Citation

We ask on the proposal form if they have ONE traditional publication they'd like users to cite.

Acknowledgement

Only if they ask for special acknowledgments like funding sources, grant numbers, etc in their proposal.

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. 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

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.

Version X (Current): Updated yyyy/mm/dd

Data TypeDownload all or Query/Filter
Images (DICOM, xx.x GB)
Clinical Data (CSV)Link
Other (format)

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