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

Colorectal Cancer Clinical Trial

— IOCCRC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01465451
• Other study ID #: SYSU 5010-2010016 IOCCRC
• 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

• Colorectal Cancer
• Colorectal Neoplasms

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