Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety (IOCCRC)
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ClinicalTrials.gov Identifier: NCT01465451 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 4, 2011
Last Update Posted
: August 11, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Procedure: curative resection for colorectal cancer Drug: intra-operative 5-FU chemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 695 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | March 2011 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ARM A- surgery alone
all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
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Procedure: curative 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.
Other Name: curative resection for colorectal cancer.
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Experimental: ARM B surgery plus chemotherapy
all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.
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Procedure: curative 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.
Other Name: curative resection for colorectal cancer.
Drug: intra-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. Other Name: intra-operative 5-FU chemotherapy for colorectal cancer
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- disease-free survival [ Time Frame: 3 years ]3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
- disease-free survival [ Time Frame: 5 years ]5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.
- safety profiles [ Time Frame: 28 days after randomization ]complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465451
China, Guangdong | |
Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | zhizhong pan, MD, PhD | Sun Yat-sen University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ZHI-ZHONG PAN, Professor, Director, M.D., Ph.D, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01465451 History of Changes |
Other Study ID Numbers: |
SYSU 5010-2010016 IOCCRC |
First Posted: | November 4, 2011 Key Record Dates |
Last Update Posted: | August 11, 2016 |
Last Verified: | August 2016 |
Keywords provided by ZHI-ZHONG PAN, Sun Yat-sen University:
colorectal cancer curative resection intra-operative chemotherapy 5-fluorouracil chemotherapy |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |