Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00726622
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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:
1. To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs.
open rectal resection (blood loss, length of stay, pain medicine utilization)
2. To assess disease free survival and local pelvic recurrence at two years.
3. To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial.
Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures ≤ 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 486
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method 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 The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with \>1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.
Length of Stay Two weeks post-surgery The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.
Completeness of Total Mesorectal Excision (Complete or Nearly Complete) At time of surgery Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.
The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI.Disease-free Survival Up to 2 years post 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 The percentage of patients with negative distal margin (\>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.
Use of Pain Medication Two weeks post-surgery The number of days patients received parenteral narcotics post-surgery were counted.
Operative Times During surgery Open to close operative time.
Trial Locations
- Locations (37)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Cancer Care Center at John Muir Health - Concord Campus
🇺🇸Concord, California, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
California Pacific Medical Center - California Campus
🇺🇸San Francisco, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
🇺🇸Walnut Creek, California, United States
Cleveland Clinic Florida - Weston
🇺🇸Weston, Florida, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Clarian North Medical Center
🇺🇸Carmel, Indiana, United States
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