Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Surgery for T4 Tumor of the Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Procedure: Laparoscopic surgery Phase 3

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3-year ]
    calculated from the date of surgery to the date of recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3-year ]
    calculated from the date of diagnosis to the date of death from any cause

  2. Adverse events (mortality and morbidity) [ Time Frame: 3-month ]
    Number of participants with treatment-related adverse events assessed by CTCAE v4.0



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Xinxiang Li, MD,PhD 86-13918176716 lxx1149@163.com
Contact: Qingguo Li, MD,PhD 86-18918298120 13111230016@fudan.edu.cn

Sponsors and Collaborators
LI XIN-XIANG
Investigators
Layout table for investigator information
Principal Investigator: Xinxiang Li, MD,PhD Fudan University

Layout table for additonal information
Responsible Party: LI XIN-XIANG, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02852915     History of Changes
Other Study ID Numbers: LapT4
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LI XIN-XIANG, Fudan University:
Colonic Neoplasms
Laparoscopic Surgery
T4
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases