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ACOSOG Z6051: A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal CancerUnique Data Set IDColorec_Allianc_2008_160
Clinical Trial Title
ACOSOG Z6051: A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
Trial Summary and Conditions
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. Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment A randomized phase III trial evaluating the safety and efficacy of laparoscopic resection for rectal cancer. Using a 1:1 randomization, patients go on to Active Comparator: 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. Experimental: 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.
Control and experimental arm data files include data on efficacy, demographics, etc. See the data dictionary provided for more details.
PRIMARY OBJECTIVES: I. 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. If all oncologic parameters are satisfied, the resection is considered successful: -- Circumferential margin > 1 mm -- Negative distal margin -- Completeness of TME (both complete and nearly complete TME) SECONDARY OBJECTIVES: I. Patient-related benefit of laparoscopic-assisted resection for rectal cancer vs. open rectal resection (blood loss, length of stay, pain medicine utilization) II. Disease-free survival and local pelvic recurrence at two years III. Quality of life, sexual function, bowel and stoma function
Primary Outcome Measures: Circumferential margin > 1 mm [ Time Frame: At time of surgery ] Negative distal resected margin [ Time Frame: At time of surgery ] Completeness of total mesorectal excision (complete or nearly complete) [ Time Frame: At time of surgery ] Secondary Outcome Measures: Patient-related benefit (length of stay, operative times and use of pain medication) [ Time Frame: Up to 5 years post surgery ] Disease-free survival [ Time Frame: Up to 2 years post surgery ] Local pelvic recurrence rates [ Time Frame: Up to 2 years post surgery ] Overall survival [ Time Frame: Up to 5 years post surgery ] Quality of life and sexual function [ Time Frame: Up to 5 years post surgery ] Bowel function [ Time Frame: Up to 5 years post surgery ] Bowel and stoma function [ Time Frame: Up to 5 years post surgery ]
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DATA DICTIONARY: Z6051_primarymanu_datadictionary_20160908.pdf