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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

Tracking Information
First Submitted Date  ICMJE November 1, 2011
First Posted Date  ICMJE November 4, 2011
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
disease-free survival [ Time Frame: 3 years ]
3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01465451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
Official Title  ICMJE 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
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.
Detailed Description nil.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: ARM A- surgery alone
    all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
    Intervention: Procedure: 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.
    Interventions:
    • Procedure: curative resection for colorectal cancer
    • Drug: intra-operative 5-FU chemotherapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 10, 2016)
695
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2011)
1246
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01465451
Other Study ID Numbers  ICMJE SYSU 5010-2010016 IOCCRC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZHI-ZHONG PAN, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: zhizhong pan, MD, PhD Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP