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Clinical Trials for the Surgical Oncologist: Opportunities and Hurdles

Abstract

Advancements in clinical practice usually require level one evidence from clinical trials that directly compare new approaches to standard of care. While clinical trials have provided data to guide advances in practices across surgical oncology, all too often accrual to clinical trials is slower than anticipated, and once results are presented and published, adoption in clinical practice is slow. Why and how can surgeons be successfully involved with clinical trials? An expert panel discusses the basic infrastructure of clinical trials, investigator-initiated trials, the National Clinical Trials Network, and opportunities for surgeon involvement. Two national clinical trials, NSABP B-51/RTOG 1304 and PROSPECT N1048, are discussed to highlight the role of the surgical oncologist.

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References

  1. Suvarna V. Investigator initiated trials (IITs). Perspect Clin Res. 2012;3(4):119–121.

    Article  Google Scholar 

  2. In: Nass SJ, Moses HL, Mendelsohn J, editors. A National Cancer Clinical Trials System for the 21st century: reinvigorating the NCI Cooperative Group Program. Washington, DC; 2010.

  3. An overview of NCI’s National Clinical Trials Network. 2018. https://www.cancer.gov/research/areas/clinical-trials/nctn#overview. Accessed 25 May 2018.

  4. National Clinical Trials Network (NCTN) Steering Committees. 2018. https://www.cancer.gov/about-nci/organization/ccct/steering-committees/nctn. Accessed 11 Nov 2019.

  5. Building on Opportunities in Cancer Reseearch. An annual plan and budget proposal for fiscal year 2016. National Cancer Institute; 2015.

  6. Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (alliance) randomized clinical trial. JAMA. 2017;318(10):918–26.

    Article  Google Scholar 

  7. Dematteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097–104.

    CAS  Article  Google Scholar 

  8. Picozzi VJ, Abrams RA, Decker PA, et al. Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031. Ann Oncol. 2011;22(2):348–54.

    CAS  Article  Google Scholar 

  9. OEWG TIMELINES AND SOPs. 2018; https://ctep.cancer.gov/protocolDevelopment/OEWG.htm#oewg_timelines_sops.

  10. Jacobs SR, Weiner BJ, Reeve BB, Weinberger M, Minasian LM, Good MJ. Organizational and physician factors associated with patient enrollment in cancer clinical trials. Clin Trials. 2014;11(5):565–75.

    Article  Google Scholar 

  11. Meropol NJ, Buzaglo JS, Millard J, et al. Barriers to clinical trial participation as perceived by oncologists and patients. J Natl Comp Cancer Netw. 2007;5(8):655–64.

    Google Scholar 

  12. Arnaout A, Kuchuk I, Bouganim N, et al. Can the referring surgeon enhance accrual of breast cancer patients to medical and radiation oncology trials? The ENHANCE study. Curr Oncol. 2016;23(3):e276-9.

    CAS  Article  Google Scholar 

  13. Bear HD, Anderson S, Brown A, et al. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003;21(22):4165–74.

    CAS  Article  Google Scholar 

  14. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: The CTNeoBC pooled analysis. Lancet. 2014;384(9938):164–72.

    Article  Google Scholar 

  15. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25–32.

    CAS  Article  Google Scholar 

  16. Mougalian SS, Hernandez M, Lei X, et al. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2(4):508–16.

    Article  Google Scholar 

  17. Early Breast Cancer Trialists’ Collaborative Group. Effects of radiotherapy and surgery in early breast cancer: an overview of the randomized trials. N Engl J Med. 1995;333(22):1444–55.

    Article  Google Scholar 

  18. EBCTCG (Early Breast Cancer Trialists’ Collaborative Group), McGale P, Taylor C, et al. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014;383(9935):2127–35.

  19. Mamounas EP, Anderson SJ, Dignam JJ, et al. Predictors of locoregional recurrence after neoadjuvant chemotherapy: results from combined analysis of National Surgical Adjuvant Breast and Bowel Project B-18 and B-27. J Clin Oncol. 2012;30(32):3960–6.

    Article  Google Scholar 

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Correspondence to Judy C. Boughey MD.

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The follow authors have no relevant financial disclosures: Park, Mamounas, Katz, Unzeitig, Carpizo, You, and Francescatti. Judy C. Boughey reports the following disclosure: research funding to my institution—Lilly. Kelly K. Hunt reports the following disclosures: Medical Advisory Board—Armada Health and Merck & Co., research funding to my institution—Endomag, Lumicell, OncoNano, Darren Carpizo is the founder and president of Z53 Therapeutics, Inc.

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Park, K.U., Mamounas, E.P., Katz, M.H.G. et al. Clinical Trials for the Surgical Oncologist: Opportunities and Hurdles. Ann Surg Oncol 27, 2269–2275 (2020). https://doi.org/10.1245/s10434-020-08472-z

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  • DOI: https://doi.org/10.1245/s10434-020-08472-z