Clinical Trial: Laparoscopic Surgery for T4 Tumor of the Colon Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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).


Sponsor: LI XIN-XIANG

Current Primary Outcome: Disease free survival [ Time Frame: 3-year ]

calculated from the date of surgery to the date of recurrence


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Fudan University

Dates:
Date Received: July 21, 2016
Date Started: October 2016
Date Completion: October 2024
Last Updated: August 3, 2016
Last Verified: August 2016