Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)

  • STATUS
    Recruiting
  • End date
    Oct 22, 2024
  • participants needed
    957
  • sponsor
    LI XIN-XIANG
Updated on 25 February 2022
open surgery
cancer
laparoscopic surgery
colon cancer
gastrointestinal surgery
colonic neoplasm
colon carcinoma

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

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 equestionnaire.

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).

Details
Condition Colonic Neoplasms
Treatment laparoscopic surgery
Clinical Study IdentifierNCT03314896
SponsorLI XIN-XIANG
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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