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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01465451
Other study ID # SYSU 5010-2010016 IOCCRC
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received November 1, 2011
Last updated August 10, 2016
Start date March 2011
Est. completion date December 2019

Study information

Verified date August 2016
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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 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.


Description:

nil.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 695
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
curative resection for colorectal cancer
right hemicolectomy for right colon cancer, transverse colectomy for transverse colon cancer, left hemicolectomy for left colon cancer, sigmoid colectomy for sigmoid colon cancer, and anterior resection or abdominal-perineal resection for rectal cancer.
Drug:
intra-operative 5-FU chemotherapy
5-FU, 1000 mg/m2, injection into bowel lumen at the beginning of resection 5-FU, 200 mg/m2, injection into portal vein via mesentery vein at the end of tumor removal and bowel reconstruction. 5-FU, 300 mg/m2, left in abdominal cavity before incision closure. surgical procedures will be the same as described in ARM A.

Locations

Country Name City State
China Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease-free survival 3 years survival of recurrence-free, metastasisi-free, death-free after randomization. 3 years No
Secondary disease-free survival 5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization. 5 years No
Secondary safety profiles complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications 28 days after randomization Yes
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