A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 37
- 主要终点
- Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.
研究概览
简要总结
This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.
详细描述
This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below.
Primary Objective:
To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation.
Secondary Objectives:
- To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs.
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
- •Eligibility Criteria:
- •Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge)
- •T3, N0, M0, T1-3, N1-2, M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible.
- •Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
- •Age ≥ 18 years
- •ECOG (Zubrod) Performance Status ≤ 2
- •Body Mass Index (BMI) ≤ 34
- •No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)
- •No systemic disease (cardiovascular, renal, hepatic) that would preclude surgery. No other severe incapacitating disease:
- •ASA IV: A patient with severe systemic disease that is a constant threat to life. OR
- •ASA V: A moribund patient who is not expected to survive without the operation.
- •No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration
- •No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
- •NOTE: Incompetent patients are not eligible for this trial.
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Open laparotomy and rectal resection
Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
干预措施: Open laparotomy and rectal resection (Procedure)
Arm 2: Laparoscopic-assisted rectal resection
Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
干预措施: Laparoscopic-assisted rectal resection (Procedure)
结局指标
主要结局
Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.
时间窗: At time of Surgery
The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation. Primary endpoint parameters: * Circumferential margin \> 1 mm * Negative distal margin * Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat. All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.
次要结局
- Disease-free Survival(Up to 2 years post surgery)
- Quality of Life and Sexual Function(Up to 5 years post surgery)
- Bowel and Stoma Function(Up to 5 years post surgery)
- Circumferential Margin > 1 mm(At time of surgery)
- Length of Stay(Two weeks post-surgery)
- Completeness of Total Mesorectal Excision (Complete or Nearly Complete)(At time of surgery)
- Local Pelvic Recurrence Rates(Up to 2 years post surgery)
- Overall Survival(Up to 5 years post surgery)
- Bowel Function(Up to 5 years post surgery)
- Negative Distal Resected Margin(At time of surgery)
- Use of Pain Medication(Two weeks post-surgery)
- Operative Times(During surgery)