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
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Procedure: Laparoscopic surgery||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1960 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2024|
Experimental: Laparoscopic surgery for T4 colon cancers
Laparoscopic surgery for T4 colon cancers
Procedure: Laparoscopic surgery
Laparoscopic surgery for T4 cancer
Other Name: Laparoscopic surgery for T4 colon cancers
No Intervention: Conventional open surgery for T4 colon cancers
Conventional open surgery for T4 colon cancers
- Disease free survival [ Time Frame: 3-year ]calculated from the date of surgery to the date of recurrence
- 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
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): NCT02852915
|Contact: Xinxiang Li, MD,PhDfirstname.lastname@example.org|
|Contact: Qingguo Li, MD,PhDemail@example.com|
|Principal Investigator:||Xinxiang Li, MD,PhD||Fudan University|