Status:
COMPLETED
Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery follow...
Detailed Description
Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the rectum
- Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
- AJCC/UICC pathologic stages of ypT3-4 or ypN+
- Curative surgery not less than 3 and not more than 8 weeks prior to randomization
- No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
- ECOG PS 0-1
- Adequate organ function
- Informed Consent
Exclusion
- Macroscopic or microscopic evidence of remaining tumor
- Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- More than 8 weeks after curative surgery
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2014
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00807911
Start Date
November 1 2008
End Date
September 5 2014
Last Update
October 23 2024
Active Locations (6)
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1
National Cancer Center
Goyang, South Korea
2
Seoul National Unversity Bundang Hospital
Seongnam, South Korea
3
Asan Medical Center
Seoul, South Korea
4
Samsung Medical Center
Seoul, South Korea