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Laparoscopic Surgery for T4 Tumor of the Colon Cancer

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ClinicalTrials.gov Identifier: NCT02852915
Recruitment Status : Not yet recruiting
First Posted : August 2, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
LI XIN-XIANG, Fudan University

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date August 4, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Disease free survival [ Time Frame: 3-year ]
calculated from the date of surgery to the date of recurrence
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02852915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Overall survival [ Time Frame: 3-year ]
    calculated from the date of diagnosis to the date of death from any cause
  • Adverse events (mortality and morbidity) [ Time Frame: 3-month ]
    Number of participants with treatment-related adverse events assessed by CTCAE v4.0
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 Laparoscopic Surgery for T4 Tumor of the Colon Cancer
Official Title  ICMJE Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
Brief Summary The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.
Detailed Description

The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity.

The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonic Neoplasms
Intervention  ICMJE Procedure: Laparoscopic surgery
Laparoscopic surgery for T4 cancer
Other Name: Laparoscopic surgery for T4 colon cancers
Study Arms  ICMJE
  • Experimental: Laparoscopic surgery for T4 colon cancers
    Laparoscopic surgery for T4 colon cancers
    Intervention: Procedure: Laparoscopic surgery
  • No Intervention: Conventional open surgery for T4 colon cancers
    Conventional open surgery for T4 colon cancers
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
1960
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to provide written informed consent
  • Histologically confirmed diagnosis of colon carcinoma
  • CT or MRI verified as T4 colon cancer without involvement of other organs
  • Without multiple lesion other than carcinoma in situ
  • Tumor size < 8 cm
  • No bowel obstruction
  • Sufficient organ function
  • No history of gastrointestinal surgery
  • 18 years of age or older
  • Performance Status (ECOG) 0, 1 or 2 and life expectancy > 12 weeks
  • Operable patients

Exclusion Criteria:

  • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
  • Unstable or uncompensated respiratory or cardiac disease
  • Serious active infections
  • Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
  • Stomatitis, ulceration in the mouth or gastrointestinal tract
  • Severe diarrhea
  • Peripheral sensory neuropathy with functional impairment
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: Xinxiang Li, MD,PhD 86-13918176716 lxx1149@163.com
Contact: Qingguo Li, MD,PhD 86-18918298120 13111230016@fudan.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852915
Other Study ID Numbers  ICMJE LapT4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LI XIN-XIANG, Fudan University
Study Sponsor  ICMJE LI XIN-XIANG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xinxiang Li, MD,PhD Fudan University
PRS Account Fudan University
Verification Date August 2016

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