Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Based on the potential advantaged of preoperative chemoradiotherapy and oral
      fluoropyrimidine, the investigators planned a 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.
    

Detailed description: 
      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.
    

Intervention name(s): Preoperative chemoradiotherapy; Postoperative chemoradiotherapy
Intervention type(s): Radiation; Radiation
Intervention description(s): Preoperative chemoradiation with conventional radiotherapy (46 Gy in 23 fractions to the whole pelvis followed by a boost dose of 4 Gy in 2 fractions) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period); Postoperative radiotherapy with conventional radiation schedule (50 Gy in 25 fractions to the whole pelvis) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
Other intervention name(s): Preoperative CCRT; Postoperative CCRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal cancer; Preoperative CCRT; Postoperative CCRT; Capecitabine