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

Phase 3

• Conditions: Colorectal Cancer
• Interventions: Procedure: curative resection for colorectal cancer; Drug: intra-operative 5-FU chemotherapy

• Registration Number: NCT01465451
• Lead Sponsor: Sun Yat-sen University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 695

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A- surgery alone	curative resection for colorectal cancer	all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
ARM B surgery plus chemotherapy	intra-operative 5-FU chemotherapy	all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.
ARM B surgery plus chemotherapy	curative resection for colorectal cancer	all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.

Primary Outcome Measures

Name	Time	Method
disease-free survival	3 years	3 years survival of recurrence-free, metastasisi-free, death-free after randomization.

Secondary Outcome Measures

Name	Time	Method
safety profiles	28 days after randomization	complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications
disease-free survival	5 years	5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.

Trial Locations

Locations (1)

Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China