Clinical Trial: Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer

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

Official Title: Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Gro

Brief Summary:

Primary Outcome Measures: Disease free survival

Secondary Outcome Measures:

Overall survival

Adverse events (Mortality, morbidity)

The proportion of completion of Laparoscopic Surgery

Estimated Enrollment: Oct, 2016

Study Start Date: Oct, 2016

Estimated Study Completion Date: Oct, 2019

Estimated Primary Completion Date: Oct, 2021

Groups/Cohorts

  1. Laparoscopic surgery for T4 colon cancers
  2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers

Detailed Summary:

Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.

The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.

Arrangements in 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.

Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two sur
Sponsor: Fudan University

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
  • The proportion of completion of laparoscopic surgery [ Time Frame: 1-month ]
    The number of completion of laparoscopic surgery/the number of participants


Original Secondary Outcome: Same as current

Information By: Fudan University

Dates:
Date Received: May 2, 2016
Date Started: October 2016
Date Completion: October 2021
Last Updated: May 17, 2016
Last Verified: May 2016