Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety (IOCCRC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
ZHI-ZHONG PAN, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01465451
First received: November 1, 2011
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Colorectal Cancer
Procedure: curative resection for colorectal cancer
Drug: intra-operative 5-FU chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    3 years survival of recurrence-free, metastasisi-free, death-free after randomization.


Secondary Outcome Measures:
  • disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.

  • safety profiles [ Time Frame: 28 days after randomization ] [ Designated as safety issue: Yes ]
    complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications


Estimated Enrollment: 1246
Study Start Date: March 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

nil.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465451

Contacts
Contact: xiaojun wu, MD, Ph.D +86 20 8734 3456 wuxj@sysucc.org.cn
Contact: niu wang +86 20 8734 3126 wangniu@sysucc.org.cn

Locations
China, Guangdong
Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: niu wang    + 86 20 8734 3126    wangniu@sysucc.org.cn   
Sub-Investigator: desen wan, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: zhizhong pan, MD, PhD Sun Yat-sen University
  More Information

No publications provided

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
Study First Received: November 1, 2011
Last Updated: November 3, 2011
Health Authority: China: Ethics Committee

Keywords provided by 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
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014