Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
This trial is active, not recruiting.
|Treatments||curative resection for colorectal cancer, intra-operative 5-fu chemotherapy|
|Sponsor||Sun Yat-sen University|
|Start date||March 2011|
|End date||December 2019|
|Trial size||695 participants|
|Trial identifier||NCT01465451, SYSU 5010-2010016 IOCCRC|
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 intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
time frame: 3 years
time frame: 5 years
time frame: 28 days after randomization
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer|
|Principal investigator||zhizhong pan, MD, PhD|
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