Colonic Neoplasms
Conditions
Keywords
Colonic Neoplasms, Laparoscopic Surgery, T4
Brief 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
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 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).
Interventions
PROCEDURELaparoscopic surgery
Sponsors
LI XIN-XIANG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-year | calculated from the date of diagnosis to the date of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 3-year | calculated from the date of surgery to the date of recurrence |
| Adverse events (mortality and morbidity) | 3-month | Number of participants with treatment-related adverse events assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactXinxiang Li, MD,PhD
Backup ContactQingguo Li, MD,PhD
Outcome results
None listed