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A091105

The Cancer Imaging Archive

A091105 | Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis

DOI: 10.7937/0WF5-SJ50 | Data Citation Required | Image Collection

Location Species Subjects Data Types Cancer Types Size Supporting Data Status Updated
Various Human 83 CT, MR Non-Cancer 278.97GB Clinical Limited, Complete 2023/02/10

Summary

This collection contains data from the Alliance for Clinical Trials in Oncology Clinical Trial NCT02066181  “Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis". Principal Investigator: Mrinal M Gounder. It was sponsored by NCI and performed by the Alliance for Clinical Trials in Oncology under study number A091105. This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Select patient-level data from this trial is available via the following link:  https://nctn-data-archive.nci.nih.gov/node/1266.

Trial Outcomes  

Results of the trial have been reported in the following publications:

  • Mazza GL, Petersen MM, Ginos B, Langlais BT, Heon N, Gounder MM, Mahoney MR, Zoroufy AJ, Schwartz GK, Rogak LJ, Thanarajasingam G, Basch E, Dueck AC. Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2. Qual Life Res. 2022 Apr;31(4):1069-1080. doi: 10.1007/s11136-021-02968-1. Epub 2021 Aug 21. Erratum in: Qual Life Res. 2021 Oct 11.
  • Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104-114. doi: 10.1177/1740774520975120. Epub 2020 Dec 1.
  • Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. doi: 10.1056/NEJMoa1805052. 

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 NCT02066181 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

Title Data Type Format Access Points Subjects Studies Series Images License
Images CT, MR DICOM
Download requires NBIA Data Retriever
83 1,140 11,977 722,626
Analysis Results Using This Collection

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:

 

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

Gounder, M. M., Mahoney, M. R., Van Tine, B. A., Ravi, V., Attia, S., Deshpande, H. A., Gupta, A. A., Milhem, M. M., Conry, R. M., Movva, S., Pishvaian, M. J., Riedel, R. F., Sabagh, T., Tap, W. D., Horvat, N., Basch, E., Schwartz, L. H., Maki, R. G., Agaram, N. P., … Schwartz, G. K. (2023). Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis (A091105) (Version 1) [Data set]. The Cancer Imaging Archive. https://doi.org/10.7937/0WF5-SJ50

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.

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 TCIA’s Helpdesk.

Publication Citation

Gounder, M. M., Mahoney, M. R., Van Tine, B. A., Ravi, V., Attia, S., Deshpande, H. A., Gupta, A. A., Milhem, M. M., Conry, R. M., Movva, S., Pishvaian, M. J., Riedel, R. F., Sabagh, T., Tap, W. D., Horvat, N., Basch, E., Schwartz, L. H., Maki, R. G., Agaram, N. P., … Schwartz, G. K. (2018). Sorafenib for Advanced and Refractory Desmoid Tumors. In New England Journal of Medicine (Vol. 379, Issue 25, pp. 2417–2428). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa1805052

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