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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Fluorouracil

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