Status:
COMPLETED
Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradio...
Detailed Description
Although there have been no confirmative data which favored preoperative chemoradiotherapy, preoperative chemoradiation have many theoretical advantage compared with postoperative one. Preoperative ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01186081
Start Date
March 1 2004
End Date
August 1 2009
Last Update
August 23 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736