Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726622
• Other study ID #: ACOSOG-Z6051
• Secondary ID: ACOSOG-Z6051U10C
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2020
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: August 1, 2019
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility Criteria:

1. Histologic diagnosis of adenocarcinoma of the rectum (= 12 cm from the anal verge)

2. 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.

3. Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.

4. Age = 18 years

5. ECOG (Zubrod) Performance Status = 2

6. Body Mass Index (BMI) = 34

7. No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)

8. 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.

9. No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration

10. 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Open laparotomy and rectal resection
Patients undergo open laparotomy and rectal resection.
• Laparoscopic-assisted rectal resection
Patients undergo laparoscopic-assisted rectal resection.

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital - Charlton Campus	Hamilton	Ontario
Canada	St. Paul's Hospital at Providence Health Care - Vancouver	Vancouver	British Columbia
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Clarian North Medical Center	Carmel	Indiana
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Boone Hospital Center	Columbia	Missouri
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Cancer Care Center at John Muir Health - Concord Campus	Concord	California
United States	Duke Cancer Institute	Durham	North Carolina
United States	Evanston Hospital	Evanston	Illinois
United States	Blodgett Hospital at Spectrum Health	Grand Rapids	Michigan
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis	Indianapolis	Indiana
United States	William N. Wishard Memorial Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Forbes Regional Hospital	Monroeville	Pennsylvania
United States	Kendrick Regional Center for Colon and Rectal Care - Mooresville	Mooresville	Indiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	INTEGRIS Cancer Institute of Oklahoma - Proton Campus	Oklahoma City	Oklahoma
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	Overlook Hospital	Summit	New Jersey
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	Cleveland Clinic Florida - Weston	Weston	Florida
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	At time of Surgery
Secondary	Completeness of Total Mesorectal Excision (Complete or Nearly Complete)	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.	At time of surgery
Secondary	Negative Distal Resected Margin	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.	At time of surgery
Secondary	Circumferential Margin > 1 mm	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.	At time of surgery
Secondary	Length of Stay	The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.	Two weeks post-surgery
Secondary	Use of Pain Medication	The number of days patients received parenteral narcotics post-surgery were counted.	Two weeks post-surgery
Secondary	Operative Times	Open to close operative time.	During surgery
Secondary	Disease-free Survival		Up to 2 years post surgery
Secondary	Local Pelvic Recurrence Rates		Up to 2 years post surgery
Secondary	Overall Survival		Up to 5 years post surgery
Secondary	Quality of Life and Sexual Function		Up to 5 years post surgery
Secondary	Bowel Function		Up to 5 years post surgery
Secondary	Bowel and Stoma Function		Up to 5 years post surgery

External Links

•   Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive