Laparoscopic Surgery for T4 Tumor of the Colon Cancer

Study Overview
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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.

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 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).

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

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Procedure: Laparoscopic surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic surgery for T4 colon cancers<br>Laparoscopic surgery for T4 colon cancers | Procedure: Laparoscopic surgery<br>* Laparoscopic surgery for T4 cancer<br>* Other names: Laparoscopic surgery for T4 colon cancers;|
| No Intervention: Conventional open surgery for T4 colon cancers<br>Conventional open surgery for T4 colon cancers | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic Neoplasms, Laparoscopic Surgery, T4