Colorectal CancerPhase 3NCT00726622
Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
A Phase 3 study testing Open laparotomy and rectal resection and Laparoscopic-assisted rectal resection in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 37 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Open laparotomy and rectal resection and Laparoscopic-assisted rectal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 37 sitesin 2 countries
- Study dates
- Aug 2008to 1 Aug 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States35 sites
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, 01805
Clarian North Medical Center
Carmel, Indiana, 46032
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Boone Hospital Center
Columbia, Missouri, 65201
John B. Amos Cancer Center
Columbus, Georgia, 31904
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, 94524-4110
Duke Cancer Institute
Durham, North Carolina, 27710
Evanston Hospital
Evanston, Illinois, 60201-1781
Blodgett Hospital at Spectrum Health
Grand Rapids, Michigan, 49506
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, 46202
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, 90027
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Forbes Regional Hospital
Monroeville, Pennsylvania, 15146
Kendrick Regional Center for Colon and Rectal Care - Mooresville
Mooresville, Indiana, 46158
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
INTEGRIS Cancer Institute of Oklahoma - Proton Campus
Oklahoma City, Oklahoma, 73142
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
California Pacific Medical Center - California Campus
San Francisco, California, 94118
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Stony Brook University Cancer Center
Stony Brook, New York, 11794-9446
Overlook Hospital
Summit, New Jersey, 07901
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, 94598
Cleveland Clinic Florida - Weston
Weston, Florida, 33331
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Canada2 sites
St. Joseph's Hospital - Charlton Campus
Hamilton, Ontario, L8N 4A6
St. Paul's Hospital at Providence Health Care - Vancouver
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
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:
- To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs. open rectal resection (blood loss, length of stay, pain medicine utilization)
- To assess disease free survival and local pelvic recurrence at two years.
- 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.
- Conditions
- Colorectal Cancer
- Being tested
- Open laparotomy and rectal resection, Laparoscopic-assisted rectal resection
- Keywords
- rectal cancer, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open laparotomy and rectal resectionProcedure or surgery
Patients undergo open laparotomy and rectal resection.
Laparoscopic-assisted rectal resectionProcedure or surgery
Patients undergo laparoscopic-assisted rectal resection.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Open laparotomy and rectal resection | Active comparator | 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. Receives: Procedure: Open laparotomy and rectal resection |
| Arm 2: Laparoscopic-assisted rectal resection | Experimental | 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. Receives: Procedure: Laparoscopic-assisted rectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of Surgery
Secondary outcomes (12)
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.
Measured: At time of surgery
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.
Measured: At time of surgery
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.
Measured: At time of surgery
Length of Stay
The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.
Measured: Two weeks post-surgery
Use of Pain Medication
The number of days patients received parenteral narcotics post-surgery were counted.
Measured: Two weeks post-surgery
Operative Times
Open to close operative time.
Measured: During surgery
Disease-free Survival
Measured: Up to 2 years post surgery
Local Pelvic Recurrence Rates
Measured: Up to 2 years post surgery
Overall Survival
Measured: Up to 5 years post surgery
Quality of Life and Sexual Function
Measured: Up to 5 years post surgery
Bowel Function
Measured: Up to 5 years post surgery
Bowel and Stoma Function
Measured: Up to 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2013
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James W. Fleshman, MD, Study chair, Baylor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726622
- Sponsor's protocol ID
- ACOSOG-Z6051
- Other IDs
- ACOSOG-Z6051, U10CA076001, NCI-2009-00350, CDR0000601816
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2008
- Last updated
- 7 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT00726622
- Acronym / sponsor ID
- ACOSOG-Z6051
- Conditions
- Colorectal Cancer
- Keywords
- rectal cancer, adenocarcinoma of the rectum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 11 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs. open rectal resection (blood loss, length of stay, pain medicine utilization)
- To assess disease free survival and local pelvic recurrence at two years.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Open laparotomy and rectal resection | Active comparator | Procedure: Open laparotomy and rectal resectionPatients 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. |
| Arm 2: Laparoscopic-assisted rectal resection | Experimental | Procedure: Laparoscopic-assisted rectal resectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open laparotomy and rectal resectionPatients undergo open laparotomy and rectal resection. | Procedure or surgery | Arm 1: Open laparotomy and rectal resection |
| Laparoscopic-assisted rectal resectionPatients undergo laparoscopic-assisted rectal resection. | Procedure or surgery | Arm 2: Laparoscopic-assisted rectal resection |
Primary outcome
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.
Time frame: 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.
12 secondary outcomes
Completeness of Total Mesorectal Excision (Complete or Nearly Complete)
Time frame: At time of surgery
Negative Distal Resected Margin
Time frame: At time of surgery
Circumferential Margin > 1 mm
Time frame: At time of surgery
Length of Stay
Time frame: Two weeks post-surgery
Use of Pain Medication
Time frame: Two weeks post-surgery
Operative Times
Time frame: During 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26441179Fleshman 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.
- Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data ArchiveLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James W. Fleshman, MD study chair
Baylor Health
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Open laparotomy and rectal resection and Laparoscopic-assisted rectal resection in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At time of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00726622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.