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Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: curative resection for colorectal cancer (Procedure); intra-operative 5-FU chemotherapy (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
zhizhong pan, MD, PhD, Principal Investigator, Affiliation: Sun Yat-sen University

Overall contact:
xiaojun wu, MD, Ph.D, Phone: +86 20 8734 3456, Email: wuxj@sysucc.org.cn

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.

Clinical Details

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

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

Primary outcome: disease-free survival

Secondary outcome:

disease-free survival

safety profiles

Detailed description: nil.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

xiaojun wu, MD, Ph.D, Phone: +86 20 8734 3456, Email: wuxj@sysucc.org.cn

Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong 510060, China; Recruiting
niu wang, Phone: + 86 20 8734 3126, Email: wangniu@sysucc.org.cn
desen wan, MD, Sub-Investigator
Additional Information

Starting date: March 2011
Last updated: November 3, 2011

Page last updated: August 20, 2015

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