Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
Although there have been no confirmative data which favored preoperative chemoradiotherapy,
preoperative chemoradiation have many theoretical advantage compared with postoperative one.
Preoperative radiotherapy with intensive short course regimen showed significant improvement
in local control even with TME, but there has been no large prospective randomized trial
which proved the efficacy of preoperative chemoradiotherapy compared with the standard
postoperative chemoradiotherapy. Although the final result of the German Trial may give the
answer for this question, there has been no randomized controlled trial which investigated
the efficacy of preoperative chemoradiotherapy using oral fluoropyrimidine which have many
theoretical and clinical advantages mentioned above; the German Trial used 5-day continuous
infusion of 5-FU. The investigators think that preoperative chemoradiotherapy with oral
capecitabine could be new standard regimen in locally advanced rectal cancer, but this
regimen must be compared with the standard postoperative chemoradiotherapy through well
designed prospective randomized trial. Based on the potential advantaged of preoperative
chemoradiotherapy and oral fluoropyrimidine, the investigators planned prospective
randomized phase III trial which compares preoperative chemoradiotherapy and postoperative
chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to
establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Jong Hoon Kim, M.D., Ph.D.
Asan Medical Center
Korea: Institutional Review Board
AMC Rectal Pre Vs Post 2004