Clinical trial NCT01465451: Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colorectal cancer
curative resection
intra-operative chemotherapy
5-fluorouracil
chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-11-04
Enrollment: 695
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: disease-free survival
timeFrame: 5 years
measure: safety profiles
timeFrame: 28 days after randomization
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: zhizhong pan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang RX, Lin JZ, Lei J, Chen G, Li LR, Lu ZH, Ding PR, Huang JQ, Kong LH, Wang FL, Li C, Jiang W, Ke CF, Zhou WH, Fan WH, Liu Q, Wan DS, Wu XJ, Pan ZZ. Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC). J Cancer Res Clin Oncol. 2017 Dec;143(12):2581-2593. doi: 10.1007/s00432-017-2489-0. Epub 2017 Aug 28.