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Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer

Phase 3
19 Years
75 Years
Not Enrolling
Rectal Cancer

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Trial Information

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.

Inclusion Criteria:

- Histologically confirmed rectal adenocarcinoma

- Tumor located below 10 cm from the anal verge

- Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography
(EUS) and computed tomography (CT)

- Patients must be > 18 years and < 76 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate bone marrow reserve

- Adequate renal function

- Adequate liver function

- Signed informed consent prior to randomization

Exclusion Criteria:

- Evidence of distant metastasis

- Previous history of chemotherapy or radiotherapy

- History of malignancy during recent 5 years other than skin cancer

- Pregnant or lactating woman

- Familial history of colorectal cancer

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

Three year

Safety Issue:


Principal Investigator

Jong Hoon Kim, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Institutional Review Board

Study ID:

AMC Rectal Pre Vs Post 2004



Start Date:

March 2004

Completion Date:

August 2009

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • Preoperative CCRT
  • Postoperative CCRT
  • Capecitabine
  • Rectal Neoplasms