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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
Sponsor:
Information provided by (Responsible Party):
ZHI-ZHONG PAN, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: curative resection for colorectal cancer Drug: intra-operative 5-FU chemotherapy Phase 3

Detailed Description:
nil.

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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.
 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.
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 years ]
    3 years survival of recurrence-free, metastasisi-free, death-free after randomization.


Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]
    5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
China, Guangdong
Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: zhizhong pan, MD, PhD Sun Yat-sen University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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