Colorectal Cancer
Conditions
Keywords
colorectal cancer, curative resection, intra-operative chemotherapy, 5-fluorouracil, chemotherapy
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.
Interventions
PROCEDUREcurative 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.
DRUGintra-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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 3 years | 3 years survival of recurrence-free, metastasisi-free, death-free after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 5 years | 5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization. |
| safety profiles | 28 days after randomization | complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications |
Countries
China
Outcome results
None listed