Status:
UNKNOWN
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative...
Eligibility Criteria
Inclusion
- histologically confirmed as adenocarcinoma of colon and rectum
- age 18-75 years
- eligible for curative surgical resection
- performance score: ECOG 0-1
- normal blood cells counts: WBC ≥ 4.0×10\*9/L，PLT ≥ 100×10\*9/L
- normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤ 1.5 ULN
- normal ECG
- no history of other malignant tumors
- no concomitant anti-cancer therapy
Exclusion
- clinical bowel obstruction
- anticipated into another clinical trial within three months
- uncontrolled infection, serious internal medical diseases
- Pregnant or lactating women
- mentally abnormal patients
- patients known allergic to 5-FU
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
695 Patients enrolled
Trial Details
Trial ID
NCT01465451
Start Date
March 1 2011
End Date
December 1 2019
Last Update
August 11 2016
Active Locations (1)
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1
Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060