Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety (IOCCRC)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
curative resection for colorectal cancer
intra-operative 5-FU chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, curative resection, intra-operative chemotherapy, 5-fluorouracil, chemotherapy
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
Sites / Locations
- Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ARM A- surgery alone
ARM B surgery plus chemotherapy
Arm Description
all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.
Outcomes
Primary Outcome Measures
disease-free survival
3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
Secondary Outcome Measures
disease-free survival
5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.
safety profiles
complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications
Full Information
NCT ID
NCT01465451
First Posted
November 1, 2011
Last Updated
August 10, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01465451
Brief Title
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
Acronym
IOCCRC
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, curative resection, intra-operative chemotherapy, 5-fluorouracil, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
695 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM A- surgery alone
Arm Type
Active Comparator
Arm Description
all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
Arm Title
ARM B surgery plus chemotherapy
Arm Type
Experimental
Arm Description
all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.
Intervention Type
Procedure
Intervention Name(s)
curative resection for colorectal cancer
Other Intervention Name(s)
curative resection for colorectal cancer.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
intra-operative 5-FU chemotherapy
Other Intervention Name(s)
intra-operative 5-FU chemotherapy for colorectal cancer
Intervention Description
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 Outcome Measure Information:
Title
disease-free survival
Description
3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
disease-free survival
Description
5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.
Time Frame
5 years
Title
safety profiles
Description
complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications
Time Frame
28 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhizhong pan, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28849265
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.
Results Reference
derived
Learn more about this trial
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
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