Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,960
- 主要终点
- Disease free survival
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Laparoscopic surgery for T4 colon cancers
Laparoscopic surgery for T4 colon cancers
干预措施: Laparoscopic surgery (Procedure)
Conventional open surgery for T4 colon cancers
Conventional open surgery for T4 colon cancers
结局指标
主要结局
Disease free survival
时间窗: 3-year
calculated from the date of surgery to the date of recurrence
次要结局
- Overall survival(3-year)
- Adverse events (mortality and morbidity)(3-month)
研究者
LI XIN-XIANG
Professor
Fudan University