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Clinically Relevant Study End Points in Rectal Cancer

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Early Gastrointestinal Cancers

Part of the book series: Recent Results in Cancer Research ((RECENTCANCER,volume 196))

Abstract

In rectal cancer currently there are no clearly validated early end points which can serve as surrogates for long-term clinical outcome such as local control and survival. However, the use of a variety of response rates (i.e. pathological complete response, downsizing the primary tumor, tumor regression grade (TRG), radiological response) as endpoints in early (phase II) clinical trials is common since objective response to therapy is an early indication of activity. Disease-free survival (DFS) has been proposed as the most appropriate end point in adjuvant trials and is one of the most frequently used in newer rectal cancer trials. Due to the devastating nature of local recurrence in locally advanced rectal cancer, local control (which is itself a subset of the overall DFS endpoint) is still considered an important endpoint. Recently, circumferential resection margin (CRM) has been proposed as novel early end point because the CRM status can account for effects on DFS and overall survival after chemoradiation, radiation (RT), or surgery alone. Consensus is needed to define the most appropriate end points in both early and phase III trials in locally advanced cancer.

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Author information

Authors and Affiliations

  1. Gastointestinal Oncology Unit, Medical Oncology Department, Fundacion Instituto Valenciano de Oncologia, Calle Gregorio Gea 31, 46009, Valencia, Spain

    Carlos Fernandez-Martos

  2. Medical Oncology Department, Fundacion Instituto Valenciano de Oncologia, Calle Gregorio Gea 31, 46009, Valencia, Spain

    Angel Guerrero

  3. Department of Radiation Oncology, MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA

    Bruce Minsky

Authors
  1. Carlos Fernandez-Martos
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  2. Angel Guerrero
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  3. Bruce Minsky
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Corresponding author

Correspondence to Carlos Fernandez-Martos .

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Editors and Affiliations

  1. Tumor- und Brustzentrum ZeTuP AG, Rorschacherstr. 150, St. Gallen, 9006, Switzerland

    Florian Otto

  2. Rheinstr. 2, Saarbrücken, 66113, Germany

    Manfred P. Lutz

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Fernandez-Martos, C., Guerrero, A., Minsky, B. (2012). Clinically Relevant Study End Points in Rectal Cancer. In: Otto, F., Lutz, M. (eds) Early Gastrointestinal Cancers. Recent Results in Cancer Research, vol 196. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-31629-6_1

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  • DOI: https://doi.org/10.1007/978-3-642-31629-6_1

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