A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 810
- 试验地点
- 158
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.
详细描述
OBJECTIVES:
- Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy.
- Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients.
- Compare the differences in costs and cost effectiveness between these treatments in this patient population.
- Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms.
The extent of colon resection is identical for both arms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Clinical diagnosis of primary adenocarcinoma
- •Involving a single colon segment:
- •Right colon from the ileocecal valve up to and including the hepatic flexure
- •Left colon from the splenic flexure to the junction of the sigmoid and descending colon
- •Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate)
- •Diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema or a colonoscopy
- •No advanced local disease that renders laparoscopic resection impossible
- •No acutely obstructed or perforated colon cancer requiring urgent surgery
- •No transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic flexure)
- •No stage IV disease
- •No rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less than 15 cm from dentate)
- •No American Society of Anesthesiologists IV/V disease classification
- •No associated gastrointestinal diseases (i.e., Crohn's, chronic ulcerative colitis, or familial polyposis) that require additional extensive operative evaluation or intervention
- •PATIENT CHARACTERISTICS:
- •18 and over
- •No other prior or concurrent malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No prohibitive scars/adhesions from prior abdominal surgery
- •No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery
排除标准
- 未提供
研究组 & 干预措施
Conventional surgery
Patients undergo open laparotomy and colectomy. A standard incision is made through the abdominal wall and the abdominal cavity is explored. A right or left colectomy or a sigmoid resection is performed.
Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms.
Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99)
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.
干预措施: conventional surgery (Procedure)
Laparoscopic-assisted colectomy
Patients undergo a laparoscopic-assisted colectomy. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with CO2 to allow access and visualization. The abdominal cavity is explored. If advanced local disease is identified, a celiotomy and colectomy are performed. Otherwise, a right or left colectomy or sigmoid resection is performed using laparoscopic-assisted techniques.
Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms.
Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99)
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.
干预措施: laparoscopic surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: Up to 8 years
Disease-free survival
时间窗: Up to 8 years
* Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. * Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. * Compare the differences in costs and cost effectiveness between these treatments in this patient population. * Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)
次要结局
- Morbidity(Up to 8 years)
- Mortality(At 30 days)
- Costs and cost effectiveness between these treatments in this patient population(Up to 8 years)
- Compare the differences in quality of life of patients treated with these regimens(Up to 8 years)