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

Sun Yat-sen University695 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

695

Conditions

Colorectal Cancer

Interventions

intra-operative 5-FU chemotherapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

disease-free survival

3 years survival of recurrence-free, metastasisi-free, death-free after randomization.

Time frame: 3 years

Secondary Outcomes

disease-free survival

5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.

Time frame: 5 years

safety profiles

complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications

Time frame: 28 days after randomization