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Laparoscopic Surgery for T4 Tumor of the Colon Cancer

Sponsor
LI XIN-XIANG (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02852915
Collaborator
(none)
1,960
Enrollment
2
Arms
96
Duration (Months)

Study Details

Study Description

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
  • 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).

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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 Names:
  • Laparoscopic surgery for T4 colon cancers

    		•
    No Intervention: Conventional open surgery for T4 colon cancers

    Conventional open surgery for T4 colon cancers

    Outcome Measures

    Primary Outcome Measures

    1. Disease free survival [3-year]

      calculated from the date of surgery to the date of recurrence

    Secondary Outcome Measures

    1. Overall survival [3-year]

      calculated from the date of diagnosis to the date of death from any cause

    2. Adverse events (mortality and morbidity) [3-month]

      Number of participants with treatment-related adverse events assessed by CTCAE v4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • LI XIN-XIANG

    Investigators

    • Principal Investigator: Xinxiang Li, MD,PhD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LI XIN-XIANG, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02852915
    Other Study ID Numbers:
    • LapT4
    First Posted:
    Aug 2, 2016
    Last Update Posted:
    Aug 4, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by LI XIN-XIANG, Professor, Fudan University
    Colonic Neoplasms
    Laparoscopic Surgery
    T4
    Additional relevant MeSH terms:
    Colonic Neoplasms

    Study Results

    No Results Posted as of Aug 4, 2016