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CompletedNCT00726622Updated May 7, 2020Results posted

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

A Phase 3 interventional study of Open laparotomy and rectal resection and Laparoscopic-assisted rectal resection in Colorectal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
486
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

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Keywords

  • rectal cancer
  • adenocarcinoma of the rectum
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 486 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
486 participants (actual)

Study arms

  • 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.

    Procedure: Open laparotomy and rectal resection

  • 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.

    Procedure: Laparoscopic-assisted rectal resection

Interventions

  • ProcedureOpen laparotomy and rectal resection

    Patients undergo open laparotomy and rectal resection.

  • ProcedureLaparoscopic-assisted rectal resection

    Patients undergo laparoscopic-assisted rectal resection.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At time of Surgery

Secondary outcomes

  1. 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.

    Time frame: At time of surgery

  2. 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.

    Time frame: At time of surgery

  3. 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.

    Time frame: At time of surgery

  4. Length of Stay

    The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.

    Time frame: Two weeks post-surgery

  5. Use of Pain Medication

    The number of days patients received parenteral narcotics post-surgery were counted.

    Time frame: Two weeks post-surgery

  6. Operative Times

    Open to close operative time.

    Time frame: During surgery

  7. Disease-free Survival

    Time frame: Up to 2 years post surgery

  8. Local Pelvic Recurrence Rates

    Time frame: Up to 2 years post surgery

  9. Overall Survival

    Time frame: Up to 5 years post surgery

  10. Quality of Life and Sexual Function

    Time frame: Up to 5 years post surgery

  11. Bowel Function

    Time frame: Up to 5 years post surgery

  12. Bowel and Stoma Function

    Time frame: Up to 5 years post surgery

07

Results

Posted Nov 11, 2016

Participant flow

Participant flow — Overall Study
MilestoneArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Started243243
Completed225240
Not completed183
Withdrew: Withdrawal by subject162
Withdrew: Physician decision01
Withdrew: Metastasis20

Outcome measures

PrimaryComparing 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.

Time frame:
At time of Surgery
Reported as:
Number · percentage of participants
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.
percentage of participantsArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
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.86.9 (82.5 to 91.4)81.7 (76.5 to 86.9)
Statistical analysis
  • Arm 1: Open Laparotomy and Rectal Resection vs Arm 2: Laparoscopic-assisted Rectal Resection · Wilcoxon (Mann-Whitney) · p = 0.41
SecondaryCompleteness 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.

Time frame:
At time of surgery
Reported as:
Number · percentage of participants
Completeness of Total Mesorectal Excision (Complete or Nearly Complete)
percentage of participantsArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Completeness of Total Mesorectal Excision (Complete or Nearly Complete)95.1 (92.2 to 97.9)92.1 (88.7 to 95.5)
SecondaryNegative 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.

Time frame:
At time of surgery
Reported as:
Number · percentage of participants
Negative Distal Resected Margin
percentage of participantsArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Negative Distal Resected Margin98.2 (96.5 to 99.95)98.3 (96.7 to 99.95)
SecondaryCircumferential 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.

Time frame:
At time of surgery
Reported as:
Number · percentage of participants
Circumferential Margin > 1 mm
percentage of participantsArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Circumferential Margin > 1 mm92.3 (88.8 to 95.8)87.9 (83.8 to 92.0)
SecondaryLength of Stay

The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.

Time frame:
Two weeks post-surgery
Reported as:
Mean · days
Length of Stay
daysArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Length of Stay7.0 ± 3.47.3 ± 5.4
SecondaryUse of Pain Medication

The number of days patients received parenteral narcotics post-surgery were counted.

Time frame:
Two weeks post-surgery
Reported as:
Mean · days
Use of Pain Medication
daysArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Use of Pain Medication4.2 ± 2.84.2 ± 3.9
SecondaryOperative Times

Open to close operative time.

Time frame:
During surgery
Reported as:
Mean · minutes
Operative Times
minutesArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Operative Times220.6 ± 92.4266.2 ± 101.9
SecondaryDisease-free Survival
Time frame:
Up to 2 years post surgery

Results for this outcome have not been posted.

SecondaryLocal Pelvic Recurrence Rates
Time frame:
Up to 2 years post surgery

Results for this outcome have not been posted.

SecondaryOverall Survival
Time frame:
Up to 5 years post surgery

Results for this outcome have not been posted.

SecondaryQuality of Life and Sexual Function
Time frame:
Up to 5 years post surgery

Results for this outcome have not been posted.

SecondaryBowel Function
Time frame:
Up to 5 years post surgery

Results for this outcome have not been posted.

SecondaryBowel and Stoma Function
Time frame:
Up to 5 years post surgery

Results for this outcome have not been posted.

Adverse events

Collected over Adverse Events were collected after surgery and were collected up to 30 days after surgery.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: Open Laparotomy and Rectal Resection—11/239 (4.6%)201/239 (84.1%)
Arm 2: Laparoscopic-assisted Rectal Resection—10/242 (4.1%)207/242 (85.5%)
Most frequent serious events
Showing 10 of 80
Most frequent serious events
EventArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Renal failureRenal and urinary disorders3/2390/242
Small intestinal obstructionGastrointestinal disorders2/2392/242
DehydrationMetabolism and nutrition disorders2/2391/242
Serum potassium increasedMetabolism and nutrition disorders2/2391/242
Abdominal distensionGastrointestinal disorders0/2392/242
Abdominal painGastrointestinal disorders0/2392/242
Fecal incontinenceGastrointestinal disorders0/2392/242
NauseaGastrointestinal disorders0/2392/242
Rectal painGastrointestinal disorders0/2392/242
Urinary retentionRenal and urinary disorders0/2392/242
Most frequent other events
Showing 10 of 282
Most frequent other events
EventArm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal Resection
Rectal painGastrointestinal disorders79/23985/242
Erectile dysfunctionReproductive system and breast disorders65/23964/242
Fecal incontinenceGastrointestinal disorders64/23953/242
NauseaGastrointestinal disorders43/23954/242
Orgasm abnormalPsychiatric disorders50/23939/242
FatigueGeneral disorders49/23948/242
Abdominal painGastrointestinal disorders32/23945/242
DiarrheaGastrointestinal disorders43/23944/242
Urinary retentionRenal and urinary disorders26/23940/242
IleusGastrointestinal disorders39/23935/242

Baseline characteristics

All patients that were randomized to a treatment arm were available for baseline characteristics. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent.

Age, Continuous
Age, Continuous(years)Arm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal ResectionTotal
Mean57.2 ± 12.157.7 ± 11.557.4 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal ResectionTotal
Female8186167
Male158156314
Region of Enrollment
Region of Enrollment(participants)Arm 1: Open Laparotomy and Rectal ResectionArm 2: Laparoscopic-assisted Rectal ResectionTotal
United States239242481
08

Study locations

37 sites
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259-5499, United States
  • Cancer Care Center at John Muir Health - Concord Campus
    Concord, California 94524-4110, United States
  • Kaiser Permanente Medical Center - Los Angeles
    Los Angeles, California 90027, United States
  • California Pacific Medical Center - California Campus
    San Francisco, California 94118, United States
  • John Muir/Mt. Diablo Comprehensive Cancer Center
    Walnut Creek, California 94598, United States
  • Cleveland Clinic Florida - Weston
    Weston, Florida 33331, United States
  • John B. Amos Cancer Center
    Columbus, Georgia 31904, United States
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Evanston Hospital
    Evanston, Illinois 60201-1781, United States
  • Clarian North Medical Center
    Carmel, Indiana 46032, United States
  • Indiana University Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Veterans Affairs Medical Center - Indianapolis
    Indianapolis, Indiana 46202, United States
  • William N. Wishard Memorial Hospital
    Indianapolis, Indiana 46202, United States
  • Kendrick Regional Center for Colon and Rectal Care - Mooresville
    Mooresville, Indiana 46158, United States
  • Holden Comprehensive Cancer Center at University of Iowa
    Iowa City, Iowa 52242-1002, United States
  • Lahey Clinic Medical Center - Burlington
    Burlington, Massachusetts 01805, United States
  • Blodgett Hospital at Spectrum Health
    Grand Rapids, Michigan 49506, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • Boone Hospital Center
    Columbia, Missouri 65201, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    Saint Louis, Missouri 63110, United States
  • Overlook Hospital
    Summit, New Jersey 07901, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
  • Stony Brook University Cancer Center
    Stony Brook, New York 11794-9446, United States
  • SUNY Upstate Medical University Hospital
    Syracuse, New York 13210, United States
  • Duke Cancer Institute
    Durham, North Carolina 27710, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • INTEGRIS Cancer Institute of Oklahoma - Proton Campus
    Oklahoma City, Oklahoma 73142, United States
  • Providence Cancer Center at Providence Portland Medical Center
    Portland, Oregon 97213-2967, United States
  • Forbes Regional Hospital
    Monroeville, Pennsylvania 15146, United States
  • Allegheny Cancer Center at Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224-1791, United States
  • Lankenau Cancer Center at Lankenau Hospital
    Wynnewood, Pennsylvania 19096, United States
  • M. D. Anderson Cancer Center at University of Texas
    Houston, Texas 77030-4009, United States
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
    Madison, Wisconsin 53792-6164, United States
  • Medical College of Wisconsin Cancer Center
    Milwaukee, Wisconsin 53226, United States
  • St. Paul's Hospital at Providence Health Care - Vancouver
    Vancouver, British Columbia V6Z 1Y6, Canada
  • St. Joseph's Hospital - Charlton Campus
    Hamilton, Ontario L8N 4A6, Canada
09

References and documents

Publications

  • Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. doi: 10.1001/jama.2015.10529. PubMed 26441179 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00726622
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 1, 2008
Start date
Aug 2008
Primary completion
Oct 2013
Completion
Aug 1, 2019
Results posted
Nov 11, 2016
Last update
May 7, 2020

Study contacts

James W. Fleshman, MD
study chair · Baylor Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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