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S0819

S0819 | A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer

DOI: 10.7937/DT39-JS04 | Data Citation Required | Image Collection

Location Species Subjects Data Types Cancer Types Size Supporting Data Status Updated
Lung Human 1,299 CT, MR, NM, PT, SC Lung Cancer 1.82TB Clinical Limited, Complete 2023/05/24

Summary

This collection contains data from the Southwest Oncology Group (SWOG) Clinical Trial NCT00946712, “Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer". Principal Investigator: Roy Herbst. It was sponsored by NCI and performed by the Southwest Oncology Group under study number S0819. This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer. Select patient-level data from this trial is available via the following link: https://nctn-data-archive.nci.nih.gov/node/850.   

Trial Outcomes  

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

  • Hirsch FR, Redman MW, Moon J, Agustoni F, Herbst RS, Semrad TJ, Varella-Garcia M, Rivard CJ, Kelly K, Gandara DR, Mack PC. EGFR High Copy Number Together With High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis From SWOG S0819, a Phase III Trial of Chemotherapy With or Without Cetuximab in Advanced NSCLC. Clin Lung Cancer. 2022 Jan;23(1):60-71. doi: 10.1016/j.cllc.2021.10.002. Epub 2021 Oct 10. 
  • Herbst RS, Redman MW, Kim ES, Semrad TJ, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold SM, Varella-Garcia M, Moon J, Mack PC, Blanke CD, Hirsch FR, Kelly K, Gandara DR. Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study. Lancet Oncol. 2018 Jan;19(1):101-114. doi: 10.1016/S1470-2045(17)30694-0. Epub 2017 Nov 20. 

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 NCT00946712 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 2: Updated 2023/05/24

Note: Corrected modality for 4 series. 1.3.6.1.4.1.14519.5.2.1.1610.1211.195814116345815233524405494571
1.3.6.1.4.1.14519.5.2.1.1610.1211.235847847475816326306023063057
1.3.6.1.4.1.14519.5.2.1.1610.1211.320794803602152686077991707326
1.3.6.1.4.1.14519.5.2.1.1610.1211.437735668159496480149708159738

Title Data Type Format Access Points Subjects Studies Series Images License
Images MR, NM, CT, SC, PT DICOM
Download requires NBIA Data Retriever
1,299 6,292 32,324 3,558,078
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

Herbst, R. S., Redman, M. W., Kim, E. S., Semrad, T. J., Bazhenova, L., Masters, G., Oettel, K., Guaglianone, P., Reynolds, C., Karnad, A., Arnold, S. M., Varella-Garcia, M., Moon, J., Mack, P. C., Blanke, C. D., Hirsch, F. R., Kelly, K., & Gandara, D. R. (2023). A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer (S0819) (Version 2) [Data set]. The Cancer Imaging Archive. https://doi.org/10.7937/DT39-JS04

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

Herbst, R. S., Redman, M. W., Kim, E. S., Semrad, T. J., Bazhenova, L., Masters, G., Oettel, K., Guaglianone, P., Reynolds, C., Karnad, A., Arnold, S. M., Varella-Garcia, M., Moon, J., Mack, P. C., Blanke, C. D., Hirsch, F. R., Kelly, K., & Gandara, D. R. (2018). Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study. In The Lancet Oncology (Vol. 19, Issue 1, pp. 101–114). Elsevier BV. https://doi.org/10.1016/s1470-2045(17)30694-0. Epub 2017 Nov 20. 

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

Previous Versions

Version 1: Updated 2023/03/30

Title Data Type Format Access Points Studies Series Images License
Images DICOM
Download requires NBIA Data Retriever