Laparoscopic Surgery for T4 Tumor of the Colon Cancer

August 3, 2016 updated by: LI XIN-XIANG

Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1960

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 3-year
calculated from the date of surgery to the date of recurrence
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3-year
calculated from the date of diagnosis to the date of death from any cause
3-year
Adverse events (mortality and morbidity)
Time Frame: 3-month
Number of participants with treatment-related adverse events assessed by CTCAE v4.0
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LI XIN-XIANG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

August 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LapT4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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