Clinically Relevant Study End Points in Rectal Cancer

  • Carlos Fernandez-Martos
  • Angel Guerrero
  • Bruce Minsky
Conference paper
Part of the Recent Results in Cancer Research book series (RECENTCANCER, volume 196)


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.


Local Recurrence Rectal Cancer Maximally Tolerate Dose Total Mesorectal Excision Circumferential Resection Margin 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Carlos Fernandez-Martos
    • 1
  • Angel Guerrero
    • 2
  • Bruce Minsky
    • 3
  1. 1.Gastointestinal Oncology Unit, Medical Oncology DepartmentFundacion Instituto Valenciano de OncologiaValenciaSpain
  2. 2.Medical Oncology DepartmentFundacion Instituto Valenciano de OncologiaValenciaSpain
  3. 3.Department of Radiation OncologyMD Anderson Cancer CenterHoustonUSA

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