Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments curative resection for colorectal cancer, intra-operative 5-fu chemotherapy
Phase phase 3
Sponsor Sun Yat-sen University
Start date March 2011
End date December 2019
Trial size 695 participants
Trial identifier NCT01465451, SYSU 5010-2010016 IOCCRC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
curative resection for colorectal cancer 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.
(Experimental)
all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.
curative resection for colorectal cancer 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.
intra-operative 5-fu chemotherapy intra-operative 5-FU chemotherapy for colorectal cancer
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.

Primary Outcomes

Measure
disease-free survival
time frame: 3 years

Secondary Outcomes

Measure
disease-free survival
time frame: 5 years
safety profiles
time frame: 28 days after randomization

Eligibility Criteria

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

Additional Information

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
Description nil.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.