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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

957 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2024-10-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic surgery for T4 colon tumor

Laparoscopic surgery for T4 colon cancers

Group Type EXPERIMENTAL

Laparoscopic surgery

Intervention Type PROCEDURE

Open surgery for T4 colon tumor

Conventional open surgery for T4 colon cancers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laparoscopic surgery

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic surgery for T4 colon cancers

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No